LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00883873979426), received between Jun 7, 2018 and Aug 31, 2026 — classified as 1 death, 99 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (33 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 30, 2024Open, Classified

   Due to an out of tolerance tool being used on monitor/defibrillator systems.

   Z-0230-2025 · Root cause: Vendor change control · FDA record ↗

2. Sep 29, 2023Open, Classified

   Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

   Z-0297-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Intermittent Loss of Power

  The customer contacted Stryker to report their device was stuck in a boot loop. 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 50517352 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT WHEN THE DEVICE IS POWERED ON, IT STAYS IN THE "SELF TEST IN PROGRESS" AND WILL NOT GO PAST THAT SCREEN. 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 25634280 ↗
• MalfunctionDec 5, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  DURING PREVENTATIVE MAINTENANCE, STRYKER OBSERVED THAT THE CUSTOMER'S DEVICE POWER BUTTON IS DIFFICULT TO OPERATE. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728176 ↗
• MalfunctionFeb 7, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOST POWER WHEN MOVED. 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 21331217 ↗
• MalfunctionDec 3, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT ON/OFF BUTTON ON THEIR DEVICE IS 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 20832337 ↗
• MalfunctionSep 18, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS STUCK ON THE SELF TEST SCREEN. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250181 ↗
• MalfunctionAug 14, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY NOT BOOT UP DURING USE. AS A RESULT, DEFIBRILLATION 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 19978873 ↗
• MalfunctionAug 6, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE UNEXPECTEDLY LOST POWER. 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 19917430 ↗
• MalfunctionMay 20, 2024Energy Output Problem; Defibrillation/Stimulation Problem; Energy Output Problem; Defibrillation/Stimulation Problem

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE EXHIBITED ENERGY DELIVERY LEVEL NOT AS EXPECTED. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355766 ↗
• MalfunctionMay 3, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT TURN ON AFTER THE BOOT-UP SCREEN. THIS CAN BE INDICATIVE OF A DEVICE LOCK-UP. 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 19237125 ↗
• MalfunctionApr 17, 2024Intermittent Loss of Power; Intermittent Loss of Power

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123422 ↗
• MalfunctionApr 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR SCREEN OF THEIR DEVICE HAD LOCKED UP DURING POWER ON. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19110865 ↗
• MalfunctionApr 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE A BOOT CYCLE. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION 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 19078619 ↗
• MalfunctionJan 16, 2024Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516068 ↗
• MalfunctionDec 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT  THEIR DEVICE INTERMITTENTLY POWER CYCLES. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384139 ↗
• MalfunctionDec 18, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT COMPLETING BOOT-UP CYCLE DURING INITIAL 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 18347373 ↗
• MalfunctionNov 28, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE POWER BUTTON OF THEIR DEVICE WILL NOT WORK PROPERLY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223047 ↗
• MalfunctionNov 27, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON. AS A RESULT, DEFIBRILLATION 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 18213335 ↗
• MalfunctionNov 20, 2023Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE AN ENERGY ERROR FAULT WHILE BEING USED TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18178471 ↗
• MalfunctionOct 17, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT START, GETTING STUCK ON THE BOOT-UP SCREEN. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950614 ↗
• MalfunctionOct 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916305 ↗
• MalfunctionOct 5, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877697 ↗
• MalfunctionSep 28, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832276 ↗
• MalfunctionSep 19, 2023Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD POWERED OFF UNEXPECTEDLY AND WOULD NO LONGER POWER ON. AS A RESULT, 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 17774079 ↗
• MalfunctionSep 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY WAS FROZEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773916 ↗