Sleep Blog

Power supply connector may fail

ResMed recalls 300,000 ‘S8’ devices worldwide

Supplemental oxygen should not
be used with identified devices

Potentially a $210 million (market cost)
problem to correct for ResMed

by Dave Jackson
National Coordinator, Awake In America
© 2007 by Dave Jackson. All rights reserved.

April 23, 2007 – ResMed, one of the leading manufacturers of equipment used to treat sleep apnea, has issued a worldwide recall for more than one-quarter of a million CPAP machines due to a potential risk with the power supply connector.

In a press release, the company indicated that specific S8 devices manufactured between July 2004 and May 15, 2006, risk a potential short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.

According to ResMed statistics, around 300,000 S8 CPAP devices, made in the earliest days of manufacturing for the product line, suffer a problem in the power supply.

The company, through the press release, said patients may continue using the S8 devices until a replacement is shipped.

What is the S8?

The S8 is a device, made by ResMed, was designed for use at home, while traveling, or in hospital or health care facilities, for the treatment of obstructive sleep apnea (OSA) in adults.

Typical selling price from Internet retailers is around $700. Using that price, this recall could potentially be valued at $210,000,000 in market dollars.

Snoring is often a symptom, as is inability to stay awake during the day. The standard treatment is continuous positive airway pressure (CPAP), a mask worn at night to keep the airway open.

Oxygen precautions

Individuals who use supplemental oxygen in conjunction with CPAP therapy should immediately contact their home care provider for a replacement. The ResMed press release urged individuals to not use oxygen with any of the S8 devices subject to the recall.

As with any electrical device, patients should make sure that it is placed on a hard clean surface and that the area around the device is clear during use. Patients should discontinue use of the device if there are any signs of electrical failure such as intermittent power, cracking sounds, sparking or charred smell.

What lead to the recall?

According to the press release, ResMed issued the voluntarily recalled for the S8 after learning that in some cases — according to its press release — around two-tenths of one-percent, a short circuit in the power supply connector has caused the S8 to fail.

ResMed has advised the U.S. Food and Drug Administration and other regulatory authorities of this action. ResMed is continuing to discuss this action with those authorities and will finalize its proposed course of action after those discussions are concluded.

In the press release, ResMed indicates the faulty component was “supplied by a third party,” but did not name the vendor or manufacturer of the component.

ResMed, in its press release, says there have been seven cases where “device failures have led to thermal damage to the device, with a remote potential to ignite material external to the device.”

Is your machine in the recall?

One of the biggest concerns many people have right now is if their machine is involved in the recall. Awake In America is republishing the list of serial numbers, in full, that are involved in the recall. The recall includes the following serial number ranges for all S8 models:

     From number     To number
     20040285613 ... 20060269563
     20060275728 ... 20060276751
     20060277160 ... 20060277415
     20060281672 ... 20060281991
     20060283424 ... 20060283743
     20060284896 ... 20060285445
     20060287568 ... 20060290823
     20060292360 ... 20060294694
     20060312361 ... 20060312597
     20060318692 ... 20060319459
     20060325074 ... 20060327794
     20060330588 ... 20060331043

Getting a replacement S8

ResMed’s S8 flow generators are distributed through medical equipment suppliers throughout the world. Affected products can be identified by the serial numbers on the bottom of each device.

According to the press release, the company is working closely with its distribution partners and the medical community to ensure patients using the S8 are aware of the recall, as well as the replacement program, and that patients who have an affected device will receive a replacement S8 flow generator.

Patients will be contacted as soon as possible to arrange for a replacement device and are encouraged to visit http://www.resmed.com/s8program for more information.

Patients in the U.S. and Canada may also contact the ResMed S8 Replacement Call Center at 888-899-8991. Contact information for patients in Latin America, Europe and Asia Pacific is available at http://www.resmed.com/s8program.

The press release went on to say there there was “No significant property damage or patient injury has been reported,” without further explanation.

FDA & MedWatch

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Contacting the FDA

• Online: MedWatch Report Form
• Regular mail: Use postage-paid FDA form 3500 (download in
  PDF format from: http://www.fda.gov/medwatch/getforms.htm
• Fax: 1-800-FDA-0178
• Mail to:
  

  MedWatch
  5600 Fishers Lane
  Rockville, MD 20852-9787

Impact on Americans’ lives

The National Institute of Neurological Disorders and Stroke (NINDS) estimates that more than 40 million Americans suffer chronic, long-term sleep disorders.

Other research, focused on a serious, potentially life-threatening condition known as sleep apnea, may impact the lives of more than 18 million Americans (about seven percent), yet only about four percent of those with apnea been diagnosed.

While 60 million Americans frequently suffer from bouts of insomnia for extended periods, another 20 million Americans experience occasional sleeping problems. These disorders and sleeping problems, coupled with the resulting sleep deprivation, interfere with family, work, driving, and social activities.

Economic impact of sleep disorders

Problems related to sleep disorders and sleep deprivation account for an estimated $16 billion in medical costs each year, according to NINDS. The indirect costs due to lost productivity and other factors are probably much greater. Doctors have identified more than 80 sleep disorders, most of which can be managed effectively once they are correctly diagnosed. The most common sleep disorders include insomnia, sleep apnea, restless legs syndrome, and narcolepsy.

Awake In America, a Philadelphia-based national non-profit organization, focused on sleep and sleep disorders. The organization aims to help educate individuals, businesses, and government officials about the importance of proper sleep, as well as provide support and education to individuals, family members, and others impacted by sleep disorders.

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It’s often been said that a little information can be a bad thing. Attorneys will often tell you that a person can know “just enough information about something to be dangerous.”

When it comes to sleep and sleep disorders, those thoughts are especially true.

For more than seven years now, on an almost daily basis — yes, Saturdays, Sundays, and holidays included! — I’ve worked with people from around the country on a variety of sleep-related issues they battle, including sleep disorders, such as sleep apnea. The worst battles I have is when someone is talking to me and says something along the line of:

Oh, no! What you’re telling me can’t be true. My great aunt Nellie’s best friend’s sister, Shania, has a pet rabbit, MoGoToPo, whose pet bedbug told me that sleep apnea isn’t serious. In fact, the bedbug, Kooka-Loca, says it is nothing more than snoring, and for me not to worry about it.

Yep, I absolutely hate when someone has a friend or family member who knows someone with a talking rabbit, and later, find out the rabbit has a talking pet bedbug. It usually turns out the bedbug, and perhaps the rabbit, are telling tall tales about things they know nothing about. In fact, that is akin to the old attorney joke that slams doctors:

Attorney 1: What do you call the guy who just graduated at the bottom of his class from medical school?
Attorney 2: Um … I don’t know. His name, maybe?
Attorney 1: No! It’s a good thing you don’t work in malpractice law. You call him the same thing you call the guy who graduated at the top of the class: Doctor.

I mention all that to discuss a blog post that a 27-year-old man mentioned to me. He person contacted me because he was diagnosed with obstructive sleep apnea only after his bedmate forced him to talk with the family doctor about snoring, gasping, and other indicators of sleep apnea. That doctor-patient talk led to an overnight sleep study, which led to him being diagnosed. Pretty cool how that works, huh? Sometimes the system really works like a finely tuned watch, but other times, it seems, things fall into an abyss.

Until he was diagnosed, everything was fine. Talking with the doctor was more of an exercise to him, just like discussing any other issue of little consequence. That all changed when he was diagnosed. He was now on the offense, waging an information warfare battle, trying to do nothing more than “prove” sleep apnea isn’t a serious health issue. In seeking out information to prove his argument, he found a blog called Sleep Facts, which had a post — “Sleep Apnea - the Silent Killer” — supporting his less-than-accurate argument.

At first glance, it sounds like the post would demonstrate apnea is a serious health issue that needs to be treated. Instead, he pointed out, first to his bedmate, then to me, a sentence from the post. It reads:

In the worst cases of sleep apnea a face mask is worn in order to prevent the air from becoming blocked and stimulate its flow.

The problem with that comment is that it sounds like only a small percentage of people diagnosed with apnea need to be treated with CPAP or bi-level (BiPAP) machines. That isn’t the case

If a person is diagnosed with apnea, the reasonable and prudent thing to do is treat it — beginning immediately. See, “the worst cases of sleep apnea” are those in which a person is diagnosed. If you’re diagnosed with having 8 or 10 apnea per hour, that’s unhealthy.

Let’s think of thing in another way: If you’re on the bus, at work, or even at the dinner table, and the person beside you stops breathing, what are you going to do? Most people immediately think of initiating cardiopulmonary resuscitation (CPR) and calling 911. The same holds true for a person who stops breathing during their sleep. Just because the situation happens in the bedroom does not mean it is any less urgent, nor does it make it taboo. In that case, though, the CPAP or BiPAP machine is at-the-ready — and should be already working and preventing apnea.

As I told the gentleman who contacted me, looking for additional resources to backup his story that apnea isn’t serious: If you put just half the effort into properly treating the apnea as you do in trying to prove it isn’t serious, you’d be a lot happier, more energetic, and on the road to preserving your health.

Until next time … sleep well!

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Complex sleep apnea clarifies some issues

For years, people have been diagnosed with apnea,
yet conventional therapies didn’t help them, at all.

While hard statistics are probably five or ten years away, it seems perhaps a small percentage of the overall apneic population has a type of apnea they claim isn’t treated by conventional therapies, including CPAP or BiPAP — using air pressure to create a patent airway during sleep — which is the gold standard of treatment for apnea.

Although these people have complained for years, not much was understood about their condition.

Complex Sleep Apnea

Researchers at the Mayo Clinic have discovered what they say is a third kind of sleep apnea. After making the discovery, they named it complex sleep apnea. Patients with complex sleep apnea at first appear to have obstructive sleep apnea and may stop breathing 20 or more times an hour.

However, when put on CPAP, the machine doesn’t completely alleviate the symptoms. Although the symptoms seem to disappear at first, then symptoms of central sleep apnea appear, again causing cessation of breathing during the night.

"All of us in our sleep lab have observed for years that there are patients who appear to have obstructive sleep apnea, but the CPAP doesn’t make them all that much better — they still have moderate to severe sleep apnea even with our best treatment and subjectively don’t feel they’re doing very well," says Timothy Morgenthaler, M.D., Mayo Clinic sleep medicine specialist, pulmonologist and lead study investigator.

"When they put on a CPAP machine, they start to look like central sleep apnea syndrome patients. This phenomenon has been observed for years, but this study is the first attempt to categorize these people," Morgenthaler added.

Understanding the types of apnea

Obstructive sleep apnea is a sleep disorder that causes a person to stop breathing dozens of times while asleep. It’s caused by an obstruction of the airways, including enlarged tonsils or adenoids, a deformed uvula or fatty tissue in the throat.

Central sleep apnea also involves stoppages in breathing during sleep. However, the cause is far different. In central sleep apnea, the brain fails to send a signal to the muscles that control breathing. Basically, the brain forgets to tell the body to breathe.

Some people have a combination of obstructive and central apnea, and are diagnosed as having mixed sleep apnea.

Causes and Treatment

So far, no known cause for complex sleep apnea has been identified but it is believed to be from a combination of physical and neurological causes. No treatment has been found. However, research continues.

Technorati Tags: obstructive sleep apnea, mixed sleep apnea, complex sleep apnea, apnea, therapies, therapy, CPAP, BiPAP, AutoPAP, xPAP, sleep apnea syndrome, sleeping, sleeps, snoring, snores, snorts, gasps, brain forgets to breathe, oxygen, central apnea, mixed apnea, complex apnea, neurological causes, no treatment, physical and neurological, combination apnea, apnoea, apnia

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