LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000061)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00883873979358), received between Jun 7, 2018 and Dec 20, 2024 — classified as 2 deaths, 48 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2024Class IIOpen, Classified

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

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

2. Sep 29, 2023Class IIOpen, Classified

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

   Z-0298-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2024Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS INTERMITTENTLY POWER CYCLING ITSELF DURING A PATIENT EVENT. A BACK UP DEVICE WAS OBTAINED TO CONTINUE PATIENT CARE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988117 ↗
• MalfunctionDec 17, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE 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 20949768 ↗
• MalfunctionJul 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT 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 19805284 ↗
• MalfunctionJul 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT COMPLETING THE BOOT UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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 19661807 ↗
• MalfunctionFeb 26, 2024Failure to Power Up; Key or Button Unresponsive/not Working; Failure to Power Up; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE COULD NOT POWER ON. 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 18776955 ↗
• MalfunctionNov 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIS DEVICE WAS LOCKED UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187912 ↗
• MalfunctionSep 26, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE HAD A DARK DISPLAY BUT THE DEVICE'S LEDS WERE ILLUMINATED. 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 17816870 ↗
• MalfunctionSep 13, 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 17738475 ↗
• MalfunctionAug 9, 2023Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT COMPLETE THE POWER ON CYCLE. 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 17495088 ↗
• MalfunctionNov 4, 2022Failure 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 COMPLETE THE BOOT UP CYCLE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730398 ↗
• MalfunctionOct 24, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT COMPLETE THE 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 15664020 ↗
• MalfunctionAug 29, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO COMPLETE THE BOOT-UP CYCLE DURING POWER ON. 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 15316534 ↗
• MalfunctionAug 29, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT CHARGING UP WHEN ATTEMPTING TO DELIVER DEFIBRILLATION THERAPY. UPON EVALUATION BY STRYKER, IT WAS ALSO FOUND THAT THE DEVICE WAS DELIVERING ABNORMAL ENERGY. IN THIS STATE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311744 ↗
• MalfunctionAug 18, 2022Failure to Charge; Inappropriate/Inadequate Shock/Stimulation; Failure to Charge; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO CHARGE FOR DEFIBRILLATION. AS A RESULT DEFIBRILLATION THERAPY WOULD BE 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 15254917 ↗
• MalfunctionJul 14, 2022Failure to Analyze Signal; Device Sensing Problem; Output Problem; Failure to Analyze Signal; Device Sensing Problem; Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR SERVICE INDICATOR WAS ILLUMINATED. IN ADDITION, THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION AND PADDLES ECG OF THE DEVICE MAY BE INOPERABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15017380 ↗
• MalfunctionSep 20, 2021Failure to Power Up; Failure to Power Up

  PHYSIO-CONTROL RECEIVED A REPORT THAT THE DEVICE "WILL NOT PASS SELF TEST" AND "DEVICE NOT COMPLETING BOOT-UP CYCLE DURING INITIAL POWER ON." IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502426 ↗
• MalfunctionAug 26, 2021Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL NOT CHARGE FOR DEFIBRILLATION - GIVES 'CONNECT ELECTRODES' OR 'ELECTRODES NOT DETECTED". IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371622 ↗
• MalfunctionJun 16, 2021Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH A PHYSIO-OWNED LOANER DEVICE. UPON EVALUATION OF THE LOANER DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS NOT COMPLETING THE BOOT UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY WOULD BE 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 12010183 ↗
• MalfunctionFeb 17, 2021Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT BUTTONS ON THEIR DEVICE WERE NOT FUNCTIONING. IN THIS STATE DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338099 ↗
• MalfunctionSep 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOCKS UP AT SELF TEST IN PROGRESS WITH SERVICE LIGHTS ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10522524 ↗
• DeathJun 22, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD TURN OFF AFTER SHOCKING THE PATIENT AND NEEDED TO BE TURNED BACK ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED. THEY REPORTED THAT THERE WAS SOME DELAY BEFORE THE PARAMEDIC NOTICED THE MONITOR SCREEN WAS BLACK. THE CUSTOMER ALLEGED THAT THERE COULD HAVE BEEN A CHANGE OF RHYTHM THAT COULD HAVE BEEN MISSED WHILE THE MONITOR WAS SHUT DOWN.

  Patient problems: Death

  MAUDE report 10179247 ↗
• MalfunctionMay 29, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS STUCK IN THE SELF TEST SCREEN. 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 Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10103581 ↗
• MalfunctionMar 25, 2020Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE FAILED TO BOOT UP.

  Patient problems: No Patient Involvement

  MAUDE report 9878355 ↗
• MalfunctionJan 20, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SWITCHED FROM PADDLES MODE TO LEAD MODE AT LEAST TWICE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9609227 ↗
• MalfunctionNov 11, 2019Electrical /Electronic Property Problem; Failure to Deliver Energy; Electrical /Electronic Property Problem; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9307517 ↗