Philips Respironics has issued updated instructions for its OmniLab Advanced+ (OLA+) Ventilator because of a demonstrated failure in the inoperative alarm that can cause an interruption or loss of therapy, according to a recall statement from the US Food and Drug Administration (FDA).
The device is used by people with obstructive sleep apnoea, apnoea, breathing problems, and mixed apnoea, and approved for children aged seven years and older, as well as adults.
The recall does not involve removal of the devices but does update usage instructions: it warns that ignoring these could result in serious injury or death, reports Medscape.
In the event of an alarm failure, the device may fail in one of two ways – by entering an inoperative state after three reboots within 24 hours (with no therapy and audible and visual alarms present), or by entering a ventilator inoperative state without rebooting first.
The alarm issue may be corrected with a software patch, available from the company, or the company will supply a replacement device until the affected products are repaired.
The statement updates a 1 April urgent recall urging the immediate removal of patients from OLA+ Ventilators and connecting them to alternative ventilation if possible if the inoperative alarm occurs.
The device failures may cause interruption or loss of therapy, with effects including anxiety, confusion/disorientation, changes in respiratory rate, dyspnoea, tachycardia, respiratory failure, and even death in especially vulnerable individuals.
One death and 15 injuries have been reported as a result of the alarm failure, according to the FDA.
Medscape article – Philips Respironics Issues Update on Ventilator Alarm Failure (Open access)
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