LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001963)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00883873871638), received between Jul 3, 2019 and Feb 28, 2025 — classified as 1 death, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2025Failure 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 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 21491505 ↗
• MalfunctionSep 11, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT MAIN KEYPAD 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 20189060 ↗
• MalfunctionAug 22, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON IS INTERMITTENTLY NOT WORKING. AS A RESULT, THE DEVICE MAY BE UNABLE TO POWER ON 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

  MAUDE report 20037831 ↗
• MalfunctionJul 31, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S LEAD AND SIZE BUTTONS ON THE MAIN KEYPAD WERE UNRESPONSIVE. 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 19878386 ↗
• MalfunctionApr 18, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132069 ↗
• MalfunctionFeb 5, 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. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638374 ↗
• MalfunctionJan 8, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD 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 18467284 ↗
• MalfunctionNov 16, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE KEPT PROMPTING "CONNECT ELECTRODES" WHEN THE DEFIBRILLATION ELECTRODES HAD ALREADY BEEN APPLIED TO THE PATIENT. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18153471 ↗
• MalfunctionOct 11, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SERVICE INDICATOR IS PRESENT AND AN EVENT CODE IS LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODE LOGGED IN ITS MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17917201 ↗
• MalfunctionAug 9, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY NOT RESPOND TO ON BUTTON PRESSES WHEN ATTEMPTED. 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 17490983 ↗
• MalfunctionJul 19, 2023Failure to Power Up; Defibrillation/Stimulation Problem; Failure to Power Up; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO BE POWERED 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 17349131 ↗
• MalfunctionApr 26, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WAS HAVING ISSUES WITH THE ON/OFF BUTTON. 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 16814473 ↗
• MalfunctionApr 26, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WAS HAVING POWER ISSUES. 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 16814018 ↗
• MalfunctionFeb 27, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER TWO SHOCKS TO A PATIENT. 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 16443806 ↗
• DeathDec 2, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO HOLD A CHARGE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED; HOWEVER, STRYKER PERFORMED A CLINICAL REVIEW, AND IT IS UNKNOWN IF THE DEVICE USED CAUSED OR CONTRIBUTED TO THE REPORTED OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909386 ↗
• MalfunctionNov 15, 2022Failure to Deliver Energy; Failure to Power Up; Defibrillation/Stimulation Problem; Failure to Deliver Energy; Failure to Power Up; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT STAY ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND 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 15799400 ↗
• MalfunctionNov 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775551 ↗
• MalfunctionOct 5, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. 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 15544554 ↗
• MalfunctionFeb 24, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  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 ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589499 ↗
• MalfunctionSep 28, 2021Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DELIVERED 3 TIMES THE SELECTED DEFIBRILLATION ENERGY DURING TESTING. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED. THE DEVICE ALSO LOGGED AN EVENT CODE IN ITS MEMORY WHICH IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER ENERGY THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540900 ↗
• MalfunctionAug 16, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  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 A FAILURE OF SEVERAL OF THE BUTTONS ON THE DEVICE CRITICAL TO DELIVERING DEFIBRILLATION THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324736 ↗
• MalfunctionDec 18, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THE CUSTOMER ADVISED THAT WHEN PERFORMING A TEST SHOCK DURING PREVENTATIVE MAINTENANCE, THE DEVICE SCREEN WENT BLANK AND FROZE FOR 7-10 SECONDS AFTER DELIVERING THE SHOCK. UPON POWERING UP, THE DEVICE SERVICE INDICATOR WAS ILLUMINATED AND THE AFOREMENTIONED EVENT CODE WAS LOGGED. ON THE DEVICE.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11042549 ↗
• MalfunctionNov 15, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S DISPLAY INTERMITTENTLY GOES BLANK. A BLANK DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. 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 9332288 ↗
• MalfunctionJul 3, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FROZE WHEN DELIVERING A SHOCK DURING TESTING. THE CUSTOMER ADVISED THAT WHEN THE SHOCK BUTTON WAS PRESSED, THE DEVICE FROZE FOR 15 SECONDS AND DID NOT INDICATE THE SHOCK WAS DELIVERED. HOWEVER THE TEST EQUIPMENT DID STATE THE SHOCK WAS DELIVERED. THE DEVICE WAS POWERED OFF AND THEN ON, THEREAFTER PROPER DEVICE OPERATION WAS OBSERVED. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED OR NOT AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8761381 ↗