LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001241)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00883873911785), received between Oct 23, 2018 and Apr 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL ONLY SHOCK INTERMITTENTLY. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880180 ↗
• MalfunctionFeb 13, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED ¿ABNORMAL ENERGY DELIVERY¿ WHEN DELIVERING DEFIBRILLATION THERAPY INTO A DEFIBRILLATION ANALYZER. THE CUSTOMER ADVISED THAT THIS WAS OBSERVED ONLY AT 30 JOULES. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO THE PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693892 ↗
• MalfunctionJan 3, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS BOOT UP CYCLE. AS A RESULT, DEFIBRILLATION THERAPY MAY 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 18433689 ↗
• MalfunctionNov 21, 2023Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  HE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS INTERMITTENTLY NOT COMPLETING THE BOOT UP PROCESS AND SHOWING A BLANK DISPLAY. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187680 ↗
• MalfunctionOct 9, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT COMPLETE BOOT-UP CYCLE DURING POWER-UP. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902205 ↗
• MalfunctionAug 22, 2023Failure to Power Up; Failure to Power Up

  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 WOULD NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596405 ↗
• MalfunctionNov 13, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY WON'T POWER ON. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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 10835429 ↗
• MalfunctionMay 26, 2020Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND IT WOULD NOT SHOW ANY ECG WAVEFORM ON THE DISPLAY. THE CUSTOMER INFORMED PHYSIO-CONTROL THAT THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10086768 ↗
• MalfunctionFeb 13, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF UNEXPECTEDLY WHILE THEY WERE PERFORMING A TEST DEFIBRILLATION SHOCK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8335840 ↗
• MalfunctionDec 11, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN POWERED ON, THEIR DEVICE'S DISPLAY FLASHES AND THEN GOES COMPLETELY BLACK. THE DISPLAY REMAINS BLACK UNTIL THEY POWER THE DEVICE OFF. THIS CAN BE INDICATIVE OF A DEVICE LOCK-UP CONDITION AND AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8153861 ↗
• MalfunctionOct 23, 2018Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF SHORTLY AFTER BEING POWERED ON. THE CUSTOMER ADVISED THAT WITH BATTERIES INSTALLED IN BATTERY WELL 1 AND 2, THE DEVICE WOULD POWER ON, BUT THEN SHORTLY THEREAFTER THE DEVICE WOULD POWER OFF. WITH A BATTERY IN WELL 2 ONLY, THE DEVICE WOULD ALSO POWER ON BUT THEN POWER OFF. WITH A BATTERY IN WELL 1 ONLY, THE DEVICE POWERED ON WITH NO ISSUES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7996335 ↗