Certain V60 and V60 Plus ventilators from Philips have been flagged for expired adhesive that can cause problems.
A total of 1,511 devices at issue were distributed in the U.S. from July 29, 2021 to August 11, 2021, according to an FDA statement.
“Philips Respironics is recalling Certain V60 and V60 Plus ventilators because a subset of these devices had parts that were put together using an expired adhesive,” The statement noted, adding that, “If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.”
Even with an alarm, the patient could still be without breathing support until a new device is connected. And without an alarm, a stopped ventilator could go unnoticed — and the patient could be deprived of oxygen — “for an extended time, which could cause serious adverse health consequences and death,” stated the agency.
To date there have been no reports of injuries or deaths linked to these devices, however.
In January, Philips sent an Urgent Medical Device Correction notice that addressed the issue and advised to “connect the ventilator to a remote alarm system, if available,” noting that “the remote alarm will provide a backup warning even if the ventilator’s primary alarm system does not alarm. It is not necessary to remove affected Philips V60/V60 Plus ventilators from service.”
In addition, the company advised using external oxygen monitoring and having “immediate access” to alternative means of ventilation.
Should the ventilator fail, Philips advised to schedule corrective maintenance.
In March, the FDA issued a notification order to the company that required it to notify patients and others of the earlier 2021 recall notice concerning CPAP and BIPAP devices over issues of degradation of the polyurethane sound abatement foam used in the devices.
After the initial issue came to light, in November 2021, the FDA has told Philips to conduct more testing on the foam it uses in ventilators that it recently recalled.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing," Philips CEO Frans van Houten said in a statement at the time