Physio-Control, Inc.: LIFEPAK 15 AC Power Adapters Recalled for Power and Charging Failure

Agency Publication Date: December 15, 2023

Summary

Physio-Control is recalling approximately 18,732 AC Power Adapters (ACPA) used with the LIFEPAK 15 Monitor/Defibrillator. These adapters may fail to charge the device's batteries or prevent the monitor/defibrillator from powering on while plugged in. This issue affects units manufactured between November 3, 2021, and April 24, 2023. If the device fails to power on or charge during a medical emergency, it could lead to a delay in critical treatment like defibrillation or patient monitoring.

Risk

The power adapter may fail to provide power or charge batteries, potentially resulting in a device that will not turn on or a depleted battery during a life-saving event. This could delay or prevent the delivery of therapy, such as electrical shocks or heart monitoring, to a patient in cardiac arrest.

What You Should Do

Identify if you have the affected AC Power Adapter by checking the reference number (REF) 11140-000098 on the adapter label.
Check for UDI-DI number 00883873940204 and verify if your unit was manufactured between November 3, 2021, and April 24, 2023.
If you identify an affected adapter, contact Physio-Control, Inc. or your healthcare provider immediately to discuss the defect and receive further instructions on replacements or alternative power solutions.
Ensure you have fully charged spare batteries available for your LIFEPAK 15 Monitor/Defibrillator to maintain operation in the event of an adapter failure.
Contact Physio-Control, Inc. at their Redmond, Washington headquarters or through their official service channels for technical support regarding this recall.
For additional questions or to report further issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator

Model / REF:

REF: 11140-000098

UDI-DI: 00883873940204

Date Ranges: Manufactured between 11/3/2021 - 4/24/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93234

Status: Active

Manufacturer: Physio-Control, Inc.

Sold By: Physio-Control, Inc.; Medical supply distributors

Manufactured In: United States

Units Affected: 18,732

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if you have the affected AC Power Adapter by checking the reference number (REF) 11140-000098 on the adapter label.

Check for UDI-DI number 00883873940204 and verify if your unit was manufactured between November 3, 2021, and April 24, 2023.

If you identify an affected adapter, contact Physio-Control, Inc. or your healthcare provider immediately to discuss the defect and receive further instructions on replacements or alternative power solutions.

Ensure you have fully charged spare batteries available for your LIFEPAK 15 Monitor/Defibrillator to maintain operation in the event of an adapter failure.

Contact Physio-Control, Inc. at their Redmond, Washington headquarters or through their official service channels for technical support regarding this recall.

For additional questions or to report further issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.