These machines to help people breathe were recalled a year ago. Many still use them

Matthew Stone, 61, was using a Philips CPAP machine for sleep apnea, but fell back on an older device from another manufacturer due to the recall. Philips spokesperson Steve Klink said in a statement that the recall was “a complex undertaking because of the sheer volume of devices to be remediated, and the outreach to every individual patient.” The company said it expects to replace or repair roughly 5.5 million devices globally, the bulk of which are CPAP or BiPAP machines. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath and black.” Klink, the Philips spokesperson, said there had been “limited complaints” about foam breakdown in prior years that were assessed on “a case-by-case basis.” He said the 220,000 complaints mentioned by the FDA were identified through “broad word searches” and that a company review found that a much smaller number — about 3% of them — were about alleged foam degradation. Some patients “do not have good alternatives except to stop the therapy,” he said, which “is not a good situation by any means.” In December, Philips said that its testing of one set of CPAP and BiPAP devices included in the recall found that the level of chemical emissions “is not typically anticipated to result in long-term health consequences for patients.” That testing did not explore the health risks from ingesting bits of foam, however, nor did it look at other devices covered by the recall. Those medical device reports, which can be submitted by health professionals and patients as well as manufacturers, do not require verification that the device caused the injury or death; Philips stressed that submitting such reports “is not evidence that the device caused or contributed to the adverse outcome or event.” However, Zuckerman said “it’s assumed that a lot of deaths and other serious injuries don’t get reported at all.” In La Quinta, Matthew P. Stone counts himself as relatively lucky.