Quote:Jenny Shields was terrified when she would awaken coughing and spitting up phlegm seeded with black specks. “I couldn’t figure out what it was,” she said... Her doctor was mystified. Eventually, Shields found out a machine she uses to control a serious medical condition had been recalled because it could spew particles and gases into the device’s air pathway.

But as the voluntary recall enters its second year, the pace is excruciatingly slow. Philips says it has repaired or replaced only about half of the 2.8 million affected devices in the United States and 3 million of the 5.5 million machines around the world. The recall, originally scheduled to be completed this fall, will stretch into next year.

That leaves millions of patients in the lurch, many of whom are railing against Philips on social media and flooding the inboxes of FDA officials with complaints. “This is dangerous, you stop breathing, that’s why you are using it,” said Christine Hinckley, who lives in Prospect, Conn. “Someone needs to do something. Months go by and you hear nothing. Nothing.”

The FDA, usually tight-lipped about companies, has taken an aggressive stance with Philips, accusing the company of being too slow in notifying consumers about machines that the agency suggests were defective from the outset... The FDA also said there was evidence some company officials knew about problems as early as 2015 — six years before the FDA was notified.

After Shields heard about the CPAP recall, the Wilmington, Del., resident stopped using the Philips machine, and the black spots in her phlegm disappeared.  Shields said she was infuriated by a lack of information from Philips. “If Honda … can track me down and tell me to replace my air bags, why can’t Philips find me?” she said.

The FDA has expressed skepticism about Philips’s test results, saying in May that certain data were “not persuasive” and rejecting the company’s argument that use of unapproved ozone cleaners is a main culprit. The agency has suggested the machines were not made properly in the first place. The FDA told The Post that many tests “are still outstanding” and that recommendations by the agency and Philips about the devices have not changed.

Tom Wilson, a retired corporate executive, began using a Philips CPAP device in spring 2018 after being diagnosed with sleep apnea. By that fall, he started coughing excessively and vomiting. In June 2021, when the recall was announced, he stopped using his machine and bought one from ResMed, another big manufacturer. Wilson now runs a Facebook support group on the Philips recall with more than 4,000 members who post about their frustration.

At Wilson’s suggestion, several members have emailed Jeffrey Shuren, director of the FDA’s device center, to complain about the difficulty of getting replacement machines. Wilson said Shuren asked him for permission to forward some of the complaints to Royal Philips’s CEO.

Quote:Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada.  Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023.

To date, Health Canada has authorized licence amendments for all DreamStation CPAP and Bi-level Therapy devices (other than DreamStation Go devices).  Philips has yet to submit packages to Health Canada for A-Series, DreamStation Go, OmniLab, and Trilogy devices.  Once a licence amendment is authorized by Health Canada, Philips has indicated that it may take up to a year for that product to be repaired or replaced.

Quote:Over 60% of the affected devices registered with Philips in Australia have now been corrected under the repair/replacement program.  There have been some delays to devices being corrected. This is due to a variety of reasons, some of which are beyond Philips' control. We are working with Philips to minimise these delays where possible.  Despite the delays, Australian patients are receiving their corrected devices ahead of many global markets.

Some patients have received replacement BiPAP devices with settings (patient scripts) that have been incorrectly installed by Philips.  Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. 

The TGA [Australia Therapeutic Goods Admin] has taken regulatory action and fined Philips for the delay in providing important information.  Philips are now required to meet weekly with the TGA to ensure that progress with the remediation plan remains on track and any further delays to the repair/replacement program are identified as soon as possible.