Respironics has issued a voluntary recall on two models of its SmartMonitor 2 Infant Apnea monitor after being notified by the U.S. Food and Drug Administration of potential problems with the product’s alarm. According to reports received by the FDA, the device may fail to sound an alarm.

The company issued a voluntary Class 1 recall, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

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Power supply connector may fail;
Supplemental oxygen should not be used with identified devices

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 that may end up potentially costing the company an estimated $210 million to correct.

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.

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.

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.

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 1-888-899-8991. 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 and 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: http://www.fda.gov/medwatch/report.htm
• Regular mail: Use postage-paid FDA form 3500 (download file 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.

Related link:

ResMed S8 Recall page