LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001960)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00883873871669), received between Sep 5, 2018 and Sep 22, 2023 — classified as 1 death, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (9 reports).

1 FDA recall record name this device's identifier, 1 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. Sep 29, 2023Class IIOpen, Classified

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

   Z-0305-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOGGED TWO CRITICAL EVENT CODES. ONE EVENT CODE LOGGED IN THE DEVICE¿S MEMORY IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY AND THE OTHER 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. DURING EVALUATION STRYKER OBSERVED THAT THE DEVICE DELIVERS ABNORMAL ENERGY. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802332 ↗
• MalfunctionSep 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO READ AN ECG SIGNAL. WITHOUT THIS FUNCTIONALITY THE NEED FOR DEFIBRILLATION THERAPY COULD NOT BE DETERMINED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720222 ↗
• MalfunctionAug 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS BOOT UP CYCLE WHEN POWERING 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 17607327 ↗
• MalfunctionAug 21, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT CHARGE OR DELIVER SHOCK. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17588483 ↗
• MalfunctionAug 7, 2023Failure to Charge; Failure to Charge

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT CHARGE TO PROVIDE DEFIBRILLATION ENERGY DURING PATIENT TREATMENT. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469309 ↗
• MalfunctionJun 6, 2023Defibrillation/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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068355 ↗
• MalfunctionMay 17, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT SHOCK AS EXPECTED WHILE IN USE WITH A PATIENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947293 ↗
• MalfunctionMay 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT BOOT UP. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915371 ↗
• MalfunctionApr 20, 2023Circuit Failure; Circuit Failure

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT RESPOND TO BUTTON PRESSES. 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 16777666 ↗
• MalfunctionMar 22, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON. 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 16591377 ↗
• MalfunctionFeb 28, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate 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 DEVICE'S MEMORY THAT 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. ADDITIONALLY, THE DEFIBRILLATOR OUTPUT ENERGY MAY BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457432 ↗
• MalfunctionJan 12, 2023Defibrillation/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 16153126 ↗
• MalfunctionAug 18, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWER BUTTON INTERMITTENTLY "STICKS". 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 THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254963 ↗
• MalfunctionAug 3, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN. 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 15157934 ↗
• MalfunctionJul 29, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WITH FULLY CHARGED BATTERIES. 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 15130545 ↗
• MalfunctionJul 12, 2022Unexpected 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 14994037 ↗
• MalfunctionJun 29, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY TURNED OFF. 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 14859780 ↗
• DeathJun 29, 2022Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO READ THE PATIENT'S ECG THROUGH THE PADDLES LEAD AND PATIENT ECG LEADS. WITHOUT THIS FUNCTIONALITY THE DEVICE WOULD NOT HAVE THE ABILITY TO FUNCTION IN AED MODE, AND THE NEED FOR DEFIBRILLATION THERAPY MAY NOT BE DETERMINED. AS A RESULT DEFIBRILLATION THERAPY MAY BE DELAYED OR WOULD NOT BE AVAILABLE IF NEEDED. A BACKUP DEVICE WAS USED AND WHEN CONNECTED TO THE DEFIBRILLATION ELECTRODES ALREADY ATTACHED TO THE PATIENT, THE ECG WAS PRESENT. THE PATIENT DID NOT SURVIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854521 ↗
• MalfunctionMar 1, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF DURING A PATIENT EVENT. 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 13636964 ↗
• MalfunctionMar 1, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK TO A PATIENT AFTER TRYING MULTIPLE TIMES. 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 13636928 ↗
• MalfunctionDec 19, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER WHILE IN USE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040790 ↗
• MalfunctionSep 21, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERS UP MOMENTARILY BUT THEN POWERS ITSELF OFF. CANNOT ENTER SET-UP MODE. 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 12507546 ↗
• MalfunctionAug 12, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THE CUSTOMER ADVISED THAT THIS OCCURRED AFTER THE DEVICE HAD BEEN ON FOR SOME TIME AND WHEN POWERED OFF, THE DEVICE WOULD NOT POWER BACK ON. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312330 ↗
• MalfunctionMar 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PHYSIO-CONTROL RECEIVED A REPORT OF A NON-CRITICAL ISSUE, BUT UPON INSPECTION, PHYSIO DETERMINED THAT THE KEYPAD WAS UNRESPONSIVE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485900 ↗
• MalfunctionMar 1, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392654 ↗