Elevated risk U.S. Food and Drug Administration

Lifepak 15 monitor/defibrillators recall: Failure to deliver a defibrillation shock after the “Shock” button

Recall published 6+ years ago

Failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressed

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
December 27, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Lifepak 15
Product type
Medical devices

Products covered by this recall

LIFEPAK 15 monitor/defibrillators

What the company announced

Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.

The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed. This is a result of oxidation that may have formed over time within the “Shock” button.

The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad. Stryker anticipates that all devices subject to this field action will be serviced by June 2021.

Most complaints associated with this issue were detected prior to patient use. Routine testing of the device can detect this fault condition. If a customer experiences this issue, they should contact Stryker as soon as possible at 1-800-787-9537 and select option 2.

The company is instructing customers to continue to use their LIFEPAK 15 monitor/defibrillator according to the Operating Instructions until the correction can be completed. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK- COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 monitor/defibrillator Operator’s Checklist, number 7).

Information about this notice is available at: http://www.strykeremergencycare.com/productnotices. Impacted customers will be notified by letter and will be requested to verify their device status.

Customers with questions regarding this notification, please contact Stryker by calling 1-800-787-9537, option 2, 8:00 A.M. to 7:00 P.M. (EST), Monday – Friday, or by email to [email protected] or 1-800- 329-7879.

In addition to contacting Stryker, any potential quality problems or adverse reactions or events associated with the use of a product from Stryker may be reported online to the U. S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program at https://www.fda.gov/safety/medwatch/ , by phone 1 800 332 1088 or fax 1 800 FDA 0178.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Device

Lifepak 15 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Remedy named in the notice: The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.

Company contact: Stryker — Consumers: Stryker, 1-800-787-9537, option 2, [email protected] — Media: Jon Zimmer, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Lifepak 15 medical devices recalled?

Failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressed The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.

Related recalls