Company: Philips Respironics, Inc.
Date of Enforcement Report: 5/23/2024
Class I

PRODUCT

OmniLab Advanced+ (OLA+) Ventilator

Recall Number:

Z-1817-2024

REASON:

Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to address the Ventilation Inoperative Alarm issue with a software patch. Alternately, Philips will offer a replacement device until these affected OLA+ devices are corrected.

The device may:

• Enter a Ventilator Inoperative state (therapy stopped, audible and visual alarms present) after three reboots within 24 hours.
• Enter a Ventilator Inoperative state without a reboot (restart) preceding this condition.

These issues can result in therapy interruption or loss, potentially leading to anxiety, confusion/disorientation, increased/decreased respiratory rate (RR), dyspnea, tachycardia (high heart rate), abnormal chest wall movement, mild to severe hypoxemia/low oxygen saturation, hypercarbia/respiratory acidosis, hypoventilation, respiratory failure, or potentially death in the most vulnerable patients.

There have been 15 reported injuries. There has been one report of death.

RECALLING FIRM/MANUFACTURER:

Philips Respironics, Inc.

VOLUME OF PRODUCT IN COMMERCE:

9,388 US; 2,664 ROW

DISTRIBUTION:

US Nationwide distribution and OUS International distribution to Canada