Philips Respironics is recalling the ventilators due to an alarm failure that can lead to therapy interruption or loss of ventilation.

Summary: Philips Respironics has issued a recall for its OmniLab Advanced+ (OLA+) ventilators due to an alarm failure that can lead to therapy interruption or loss of ventilation. The recall involves updating usage instructions, applying software patches, or providing replacement devices. The FDA identified this as the most serious type of recall, citing 15 injuries and one death. The OLA+ ventilator is used in hospitals and sleep laboratories for patients with obstructive sleep apnea and other breathing difficulties.

Key Takeaways:

  • Alarm Failure: The recall addresses a critical ventilator inoperative alarm failure, which can interrupt therapy or stop ventilation.
  • FDA Classification: The FDA classifies this as the most serious type of recall, with 15 injuries and one reported death.
  • Corrective Actions: Philips is offering software patches and replacement devices to ensure the safety and continued therapy for affected patients.

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.

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold, according to a recall notice from the US Food and Drug Administration (FDA). The FDA has identified this recall as the most serious type. There have been 15 reported injuries. There has been one report of death.

The OLA+ Ventilator is used to help patients with obstructive sleep apnea (OSA), breathing difficulties, and mixed types of apnea. It can be used for children aged 7 and older who weigh more than 40 pounds, as well as for adults weighing more than 66 pounds. The device is designed for use in hospitals and sleep laboratories.

What to Do

On April 1, Philips Respironics sent all affected customers an urgent medical device recall recommending the following actions:

  • If a ventilator inoperative alarm occurs, immediately remove the patient from the device and connect them to an alternate source of ventilation, if available.
  • As an optional step/action, an attempt to perform a “hard reboot” (forced device restart) that may temporarily restore device function, should be taken.
  • Contact Philips for the software patch to the Ventilation Inoperative Alarm issue.
  • Complete and return the response form included in this notice.

Reason for Updates to Use Instructions

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.

Device Use

The OLA+ Ventilator helps people breathe by providing two different pressure levels. This makes it more comfortable for patients to receive breathing support. The device also has a feature called Bi-Flex, which makes it easier to switch from breathing in to breathing out by reducing pressure during exhalation. It offers various modes of therapy, including:

  • Continuous Positive Airway Pressure
  • Spontaneous mode
  • Spontaneous/Timed mode
  • Timed mode
  • Pressure Control modes with optional Bi-Flex or AVAPS (average volume assured pressure support) features, as set by a healthcare professional.

Affected Product

  • Product Names: OmniLab Advanced+ (OLA+) Ventilator
  • Unique Device Identifier (UDI)/Model: See all affected devices
  • Lot/Serial Numbers: Class 1 Device Recall OmniLab Advanced (