U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy
  1. Medical Device Recalls

Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy

July 16, 2024

The FDA is continuing its evaluation of the number of reports associated with this recall, and we will update the information when it is available.

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

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 (fda.gov)

What to Do

  • If interruptions of therapy can be tolerated and the ventilator inoperative (vent inop) alarm occurs, the patient/caregiver will have instructions to remove the patient from the device and to place them on an alternative device.
  • If interruptions of therapy cannot be tolerated, the patients and caregivers are instructed to provide alternate ventilation AND contact the Equipment Supplier for immediate device alternative.

On April 1, 2024, Philips Respironics, Inc. 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

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.

Device Use

The OmniLab Advanced+ (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 (CPAP)
  • 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.

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.

Contact Information

Customers in the U.S. with questions about this recall should contact Philips Respironics, Inc. at 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com.

Full List of Affected Devices (if applicable)

  • 1111122 / UDI-DI 606959067813
  • 1111123 / UDI-DI 606959067820
  • 1111124/ UDI-DI 606959067837
  • 1111125/ UDI-DI 606959067844
  • 1111126/ UDI-DI 606959067851
  • 1111127/ UDI-DI 606959067868
  • 1111138/ UDI-DI 606959067875
  • 1111141/ UDI-DI 606959067929
  • 1111142/ UDI-DI 606959067905
  • KR1111127/ UDI-DI 606959067912
  • R1111122/ UDI-DI 606959067981
  • R1111123/ UDI-DI 606959067998
  • R1111124/ UDI-DI 606959068001
  • U1111122/ UDI-DI OBS- 00606959408777
  • U1111124/ UDI-DI 606959077324

Additional FDA Resources (listed in order of most to least recent):

Additional Company Resources (listed in order of most to least recent):

Company provided information on a recall, is posted here by the FDA as a public service.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

 

Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.

Back to Top