Philips replaces recalled CPAP machine with another recalled machine

Company says refurbished machine is safe

Company says refurbished machine is safe

The latest breaking updates, delivered straight to your email inbox.

Company says refurbished machine is safe

Philips Respironics has promised to replace millions of CPAP and BiPAP breathing machines that FDA reports have linked to thousands of injuries and more than 300 deaths.

More than two years after the recall, Don Schreiber of Pleasant Hills finally got a replacement machine.

When he got his new CPAP, he checked the serial number and found that it, too, was on the recall list.

“Philips promised a replacement machine and two years later, I finally get this. And it's under recall, too,” Schreiber said. “It’s very frustrating.”

Philips sent him a note with the new machine note saying the foam in the recalled machine had been replaced with a silicone foam allowed by the FDA. The note also said the refurbished machine met “standards of safety, performance and quality.”

But Schreiber and his wife Denise are not so sure.

“I'll start to use it, but I'm still going to have a grain of thought and probably something in the back of my mind saying, what happens if I get sick?” Schreiber said.

“We'd like to enjoy our lives. And I know it's for better or for worse, but I don't want to spend the rest of our lives with me taking care of a sick man in the hospital because the machine screwed him up,” Denise Schreiber said.

A statement from Philips said in part, "The remediation program is a mix of repaired and new devices. To be clear, with repaired devices the vital elements, such as the blower box and blower motor, are replaced with new parts."

Philips also said multiple studies have shown "no excess risk of cancer" for sleep apnea patients using the recalled machines.

“I have no confidence at all in Philips at this point,” Denise Schreiber said.

About 60,000 customers have sued Philips seeking millions of dollars in damages due to the recalled machines. It could be several years before those lawsuits are resolved.

An FDA report about medical device reports says, “Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.”