Amid Massive Recall, Philips Reports Issues With Some Repaired Devices - Medpage Today

As Philips' subsidiary Philips Respironics continues a sprawling repair and replacement program for 5.5 cardinal breathing machines successful the aftermath of a June 2021 callback chiefly owed to imaginable wellness risks from polyester-based polyurethane (PE-PUR) dependable abatement foam, caller issues are plaguing immoderate of the repaired devices.

In mid-November, the FDA issued an update to the callback that affected definite continuous affirmative airway unit (CPAP) and bilevel affirmative airway unit (BiPAP) machines and mechanical ventilators, stating that Philips had informed the bureau that reworked Philips Respironics Trilogy ventilators person 2 caller imaginable issues.

First, the silicone dependable abatement foam installed successful the devices to regenerate the PE-PUR foam has the imaginable to abstracted from integrative backing and could interaction the show of the instrumentality by perchance blocking the aerial inlet, frankincense lowering inspiratory pressure. If the aerial unit is importantly impacted, the instrumentality could contented a ventilator alarm, specified arsenic the debased inspiratory unit alarm.

Furthermore, hint amounts of particulate substance person been recovered successful the aerial pathway of immoderate of the reworked ventilators. Preliminary laboratory results from a 3rd enactment identified PE-PUR and biology debris successful immoderate samples, and lone biology debris successful others.

For Philips, which besides issued a nationalist update connected the matter past week, the caller issues people a setback for its ongoing repair efforts. As Philips Respironics investigates the issues, it has temporarily suspended the repair of Trilogy 100/200 devices, according to the update.

A spokesperson for Philips provided further discourse connected the caller issues successful an email to MedPage Today, penning successful portion that, "It is important to enactment that this lone affects Trilogy 100/200 ventilators (approximately 3% of the registered affected devices globally), which person already been repaired. These problems bash not impact immoderate of the CPAP oregon BiPAP slumber apnea devices that person been remediated."

In its update, Philips said the repair of Trilogy 100/200 ventilators has begun successful caller months, and that Philips Respironics detected the 2 problems with the corrected ventilators "following a constricted fig of complaints from the U.S. and Japan."

Elaborating connected the contented of silicone foam separation, Philips said that, arsenic of November 1, the observed occurrence complaint of reportable events was little than 0.015% of corrected Trilogy 100 devices. Based connected the latest disposable information, the basal origin was linked to an assembly measurement successful inserting the silicone foam, the institution noted.

Additionally, pending an probe into some of the caller issues, Philips Respironics plans to instrumentality due enactment if required.

When it comes to the CPAP and BiPAP machines included successful the June 2021 recall, Philips stated successful its update that they comprise astir 95% of the affected devices, adding that the repair and replacement of those devices is "well underway globally."

Specifically, the spokesperson told MedPage Today that "more than 4 cardinal replacement devices and repair kits person been produced, of which astir 2 cardinal person been shipped to the U.S."

Shannon Sullivan, MD, a pediatric slumber medicine specializer astatine Stanford Medicine and seat of the American Academy of Sleep Medicine's nationalist information committee, told MedPage Today that it's hard to cognize wherever determination whitethorn inactive beryllium occupation spots crossed the U.S. successful presumption of patients waiting connected repaired oregon replaced slumber apnea devices. However, astatine her practice, the bulk of cases person been mitigated successful 1 mode oregon another, she said.

Many patients' CPAP oregon BiPAP machines person been repaired oregon replaced astatine this point, portion different patients person transitioned to a antithetic marque oregon therapy, she added.

Still, determination is the occasional diligent who comes into the session believing their instrumentality isn't affected erstwhile it is, she said, noting that she besides worries astir patients who don't person oregon haven't been successful interaction with a slumber medicine doc to sermon mitigation measures.

Last week, the FDA issued different update that included information connected aesculapian instrumentality reports (MDRs) received from August 1 to October 31 that are reportedly associated with the breakdown oregon suspected breakdown of PE-PUR foam utilized successful the breathing devices included successful the recall.

During the astir caller period, determination were much than 21,000 MDRs received, including 91 reports of deaths.