LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001951)Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00883873871751), received between May 8, 2018 and Aug 21, 2024 — classified as 1 death, 87 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (19 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 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID RECOGNIZE THE PADDLES LEAD AND WERE UNABLE TO OBTAIN AN ECG. 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 20022208 ↗
• MalfunctionAug 19, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE DELIVER ENERGY. 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 19999469 ↗
• MalfunctionJun 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP 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 19614385 ↗
• MalfunctionJun 12, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH CAN BE ASSOCIATED WITH A MONOPHASIC SHOCK DELIVERY. 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 19521716 ↗
• MalfunctionJun 10, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT 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 19506151 ↗
• MalfunctionMay 8, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION, STRYKER OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266947 ↗
• MalfunctionApr 11, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INVESTIGATION, STRYKER OBSERVED THAT THE CUSTOMER'S DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085772 ↗
• MalfunctionApr 2, 2024Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED EVENT CODES THAT IS INDICATIVE OF A DEVICE FAILURE OF PROVIDING DEFIBRILLATION ENERGY AND ASSOCIATED WITH MONOPHASIC SHOCK. AS A RESULT, WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020272 ↗
• MalfunctionFeb 29, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD UNEXPECTEDLY SHUT DOWN IMMEDIATELY UPON POWERING IT ON. 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 18806253 ↗
• MalfunctionFeb 27, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE THERAPY CABLE CONNECTION ON THEIR DEVICE IS DAMAGED. THE CABLE WILL NOT STAY PLUGGED IN. 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 18787282 ↗
• MalfunctionFeb 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOCKED UP WHEN CHARGING DEFIBRILLATION. 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 18763708 ↗
• MalfunctionJan 31, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE DELIVER ENERGY. 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 18612912 ↗
• MalfunctionJan 30, 2024Failure to Analyze Signal; Failure to Sense; Failure to Analyze Signal; Failure to Sense

  THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NOT PASS THE ELECTRIC RESISTANCE TEST AND WOULD NOT DETECT THE QUIK-COMBO ELECTRODES. AS A RESULT, THE DEVICE WOULD NOT DETECT THE PATIENT AND 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 18610698 ↗
• MalfunctionDec 21, 2023Power Problem; Unexpected Shutdown; Power Problem; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY GOES BLANK AND THE DEVICE LOSES POWER. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378906 ↗
• MalfunctionNov 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE COULD NOT BE USED DURING PATIENT USE. A A RESULT, THE DEVICE MAY HAVE BEEN IN A LOCK UP CONDITION 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 18088803 ↗
• MalfunctionOct 10, 2023Unexpected 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 17907245 ↗
• MalfunctionOct 9, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SERVICE INDICATOR IS PRESENT AND AN EVENT CODE IS LOGGED IN THEIR DEVICE'S MEMORY IN ADDITION TO NOT DELIVERING DEFIBRILLATION. THE EVENT CODE LOGGED IN ITS MEMORY INDICATES 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. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902191 ↗
• MalfunctionSep 18, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765938 ↗
• MalfunctionSep 18, 2023Electrical /Electronic Property Problem; Key or Button Unresponsive/not Working; Electrical /Electronic Property Problem; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWER BUTTON HAD TO BE PRESSED MULTIPLE TIMES POWER ON. ONCE THE DEVICE DID POWER ON, 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 17764028 ↗
• MalfunctionSep 12, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730776 ↗
• MalfunctionAug 9, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE SHOCK. 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 17487944 ↗
• MalfunctionAug 9, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486793 ↗
• MalfunctionJul 19, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352138 ↗
• MalfunctionJun 14, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT RECOGNIZE THE DEFIBRILLATION ELECTRODES WHEN CONNECTED TO A PATIENT. 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 EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131055 ↗
• MalfunctionJun 1, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD UNEXPECTEDLY LOOSE POWER. 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 EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037126 ↗