LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001257)Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00883873911617), received between Mar 27, 2018 and Jun 14, 2024 — classified as 3 deaths, 88 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (50 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIS DEVICE WOULD POWER OFF RANDOMLY. AS A RESULT, DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542564 ↗
• MalfunctionJun 11, 2024Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE FAILED TO DELIVER ENERGY AS EXPECTED. IN THIS STATE DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509410 ↗
• MalfunctionJan 31, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617406 ↗
• MalfunctionJan 17, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERS OFF. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524523 ↗
• MalfunctionJun 2, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT SOME BUTTONS ON THEIR DEVICE ARE NOT WORKING. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051317 ↗
• MalfunctionMay 25, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DELIVER DEFIBRILLATION SHOCK WHEN ATTEMPTED. AS A RESULT, THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001000 ↗
• MalfunctionFeb 4, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD UNEXPECTEDLY LOOSE POWER. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300886 ↗
• MalfunctionJan 27, 2023Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE DISPLAYED A MESSAGE INDICATING ABNORMAL ENERGY WAS DELIVERED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258956 ↗
• MalfunctionNov 17, 2022Inappropriate/Inadequate Shock/Stimulation; Aborted Charge; Inappropriate/Inadequate Shock/Stimulation; Aborted Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY DUMPED THE DEFIBRILLATION ENERGY DURING A PATIENT EVENT. THE CUSTOMER FURTHER ADVISED A SHOCK WAS NOT ULTIMATELY REQUIRED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820486 ↗
• MalfunctionAug 16, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE DEVICE HAD AN ERROR CODE INDICATING A FAILURE TO COMPLETE THE BOOT UP CYCLE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233663 ↗
• MalfunctionAug 4, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE INTERMITTENTLY WOULD POWER OFF BY ITSELF. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THERE WAS NO REPORT OF PATIENT USE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15169089 ↗
• MalfunctionJul 14, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S CONTROL PANEL BUTTONS WERE INTERMITTENTLY FUNCTIONAL. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021863 ↗
• MalfunctionJun 22, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT NON OF THE BUTTONS ON THEIR DEVICE ARE WORKING ASIDE FROM THE ON/OFF BUTTON. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THE BUTTONS STARTED WORKING AGAIN AFTER THE DEVICE WAS POWER CYCLED MULTIPLE TIMES. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775338 ↗
• MalfunctionJun 3, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14585748 ↗
• MalfunctionMay 18, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING REVIEW OF THEIR DEVICE'S TRANSMITTED RECORDS THEY SAW AN ABNORMAL ENERGY SHOCK. IN THIS STATE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428812 ↗
• MalfunctionMay 13, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THE DEVICE'S MAIN KEYBOARD UNRESPONSIVE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399331 ↗
• MalfunctionMar 28, 2022Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED "ABNORMAL ENERGY DELIVERED" WHEN SHOCKING. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933165 ↗
• MalfunctionJan 28, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF DURING USE AND INDICATED A SERVICE LED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385478 ↗
• MalfunctionDec 30, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS INTERMITTENTLY POWERING OFF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122643 ↗
• MalfunctionDec 28, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY TURNED OFF AFTER PRINTING. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ventricular Fibrillation

  MAUDE report 13096690 ↗
• MalfunctionDec 20, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTDOWN. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046928 ↗
• MalfunctionDec 20, 2021Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS DISPLAYING "ABNORMAL" AFTER EACH SHOCK IS DELIVERED. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046911 ↗
• MalfunctionDec 3, 2021Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY WENT OFF DURING USE. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924112 ↗
• MalfunctionNov 30, 2021Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF AND WOULD NOT COMPLETE THE BOOT UP PROCESS WHEN THEY ATTEMPTED TO POWER IT BACK ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896333 ↗
• MalfunctionNov 17, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832674 ↗