LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00883873905609), received between Aug 9, 2018 and Aug 15, 2025 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (13 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE 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 22813694 ↗
• MalfunctionOct 3, 2024Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE DID NOT CHARGE TO SHOCK. 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 20364146 ↗
• MalfunctionOct 2, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, 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 20350900 ↗
• MalfunctionMay 14, 2024Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S SERVICE INDICATOR IS PRESENT AND THERE IS AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY CAN INDICATE THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE. AS A RESULT, THE UNIT MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF IT WAS NECESSARY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316289 ↗
• MalfunctionApr 25, 2024Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, STRYKER OBSERVED THAT THE DEFIBRILLATION ENERGY TOLERANCE WAS OUT OF RANGE. IN THIS STATE AN INAPPROPRIATE ENERGY MAY BE DELIVERED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180055 ↗
• MalfunctionApr 12, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD UNEXPECTEDLY LOST POWER. AS A RESULT, 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 19094866 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD A BROKEN THERAPY CONNECTOR. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978430 ↗
• MalfunctionFeb 15, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED 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 18711564 ↗
• MalfunctionFeb 2, 2024Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEY WERE UNABLE TO CONNECT THE THERAPY CABLE. 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 18636439 ↗
• MalfunctionDec 20, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. 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 18365894 ↗
• MalfunctionNov 29, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF WHILE ATTACHED TO A PATIENT. 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 18233841 ↗
• MalfunctionNov 7, 2023Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON INSPECTION, STRYKER OBSERVED THAT THE DEVICE WAS DISPLAYING "ABNORMAL ENERGY DELIVERY" MESSAGE AND NO ENERGY WAS DETECTED TO BE DELIVERED. AS A RESULT, APPROPRIATE DEFIBRILLATION THERAPY WOULD NOT BE DELIVERED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085787 ↗
• MalfunctionOct 30, 2023Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE PROMPTED, "ATTACH PADS". THE CUSTOMER ADVISED THAT THE PATIENT WAS BEING PACED. WHEN THEY ARRIVED AT THEIR DESTINATION, THE REPORTED MESSAGE PROMPT WAS OBSERVED. IT WAS NOTED AT THE TIME THAT THE PATIENT WAS IN ASYSTOLE. IN THIS STATE, THE DEVICE COULD DELAY OR PROHIBIT THE DELIVERING OF DEFIBRILLATION THERAPY TO A PATIENT IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: Asystole

  MAUDE report 18030333 ↗
• MalfunctionJul 11, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD ILLUMINATED ITS SERVICE LED AND WOULD NOT PROVIDE DEFIBRILLATION ENERGY 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 17299927 ↗
• MalfunctionMay 15, 2023Failure to Sense; Key or Button Unresponsive/not Working; Failure to Sense; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT CONTROLS ON THEIR DEVICE ARE UNRESPONSIVE AND THAT THEY ARE UNABLE TO CONNECT THERAPY CABLE. 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 16935806 ↗
• MalfunctionApr 17, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER HAD SENT IN THEIR DEVICE FOR REPAIR. DURING INSPECTION, IT WAS OBSERVED THAT THE DEVICE HAD DISPLAYED 'ABNORMAL ENERGY DELIVERY MESSAGE'. AS A RESULT, PROPER 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 16756109 ↗
• MalfunctionMar 9, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE "TAKES ABNORMALLY LONG TIME TO CHARGE". IN THIS STATE DEFIBRILLATION THERAPY WOULD BE DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518428 ↗
• MalfunctionMar 9, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S MAIN KEYPAD WAS NOT WORKING. 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 16510741 ↗
• MalfunctionNov 15, 2022Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO SELECT PADDLE LEAD ECG. 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 15802025 ↗
• MalfunctionOct 11, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED AN ERROR WHEN THE SHOCK BUTTON WAS PRESSED. 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 15584265 ↗
• MalfunctionSep 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT AFTER INITIAL BOOTUP, THE DEVICE WENT INTO A CYCLE OF CONTINUOUS REBOOT. 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 15510036 ↗
• MalfunctionSep 12, 2022Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402483 ↗
• MalfunctionJul 21, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE REPEATEDLY POWER OFF. 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 15080690 ↗
• MalfunctionJun 29, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE BUTTONS ON THEIR DEVICE ARE NOT WORKING. 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 14854567 ↗
• MalfunctionMar 17, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR MONITOR WOULD UNEXPECTEDLY TURN OFF WHEN BUMPED. 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 13792996 ↗