- Philips has started another recall of respiratory devices, flagging up problems with its Respironics V60 and V60 Plus ventilators that could cause serious injuries or death.
- The recall, which is unrelated to the massive effort covering sound abatement foam, began when Philips discovered that some ventilators were assembled using expired adhesive. If the adhesive fails, the device could stop providing ventilation to the patient.
- Philips is keeping the devices on the market and asking healthcare professionals to take precautions when patients use the affected ventilators. FDA is yet to receive reports of injuries or deaths linked to the 1,511 devices covered by the recall, but the agency is treating the problem as a high-risk Class I event.
The quality standards of Philips' respiratory business have been in the spotlight since the company began recalling millions of sleep apnea devices and ventilators over concerns the sound abatement foam may break down and expose patients to toxic chemicals.
A separate recall of V60 ventilators started weeks later in response to the discovery the devices may provide the patient with a lower oxygen flow rate. The problem caused 25 injuries at the time of the recall.
Philips began the latest recall of V60 ventilators in January. The recall, which is distinct from the flow rate problem, covers 1,511 devices distributed over a two-week period last summer. Philips put the devices together using an expired adhesive. FDA set out the potential implications of that quality failure in its notice to communicate the Class I recall.
"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," the agency wrote.
The effect of the cessation of ventilation on the patient will depend on whether an alarm sounds. In the worst-case scenario, the lack of an alarm could leave the patient deprived of oxygen for "an extended time," FDA said, potentially leading to serious adverse health consequences and death.
Philips asked users of affected devices to connect their ventilators to remote alarm systems, if available, when it first communicated the problem to customers in January. The remote alarm provides a backup that should sound even if the ventilator's primary alarm system fails to go off.
Other recommended precautions include the provision of external oxygen monitoring to minimize patient risk if the device fails.
News of the recall comes months after Philips expanded its program to repair and replace devices that use the potentially harmful sound abatement foam.