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
