LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 00883873912782), received between Apr 23, 2018 and Sep 2, 2026 — classified as 4 deaths, 1 injury, 229 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (112 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 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564924 ↗
• MalfunctionJun 26, 2026Failure to Analyze Signal

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE DEVICE'S AED FUNCTION IS INOPERATIVE ALONG WITH PADDLES ECG. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635162 ↗
• MalfunctionJun 19, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER. 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 25562838 ↗
• MalfunctionDec 1, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT  THEIR DEVICE DOES NOT POWER 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 23682755 ↗
• MalfunctionAug 12, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHOWED AN "ENERGY FAULT" MESSAGE WHEN THE DEVICE WAS CHARGED FOR DEFIBRILLATION. 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 22780916 ↗
• MalfunctionJul 15, 2025Failure to Power Up; Connection Problem; Failure to Power Up; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. ADDITIONALLY, THE THERAPY CONNECTOR IS DAMAGED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505923 ↗
• MalfunctionMay 30, 2025Aborted Charge; Aborted Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT DUMP DEFIBRILLATION ENERGY. 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 22115027 ↗
• MalfunctionMay 15, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF WITHOUT WARNING. 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 22027657 ↗
• MalfunctionMar 21, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON WORKS INTERMITTENTLY. 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 21668843 ↗
• MalfunctionMar 3, 2025Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWER CYCLED DURING USE AND THERE IS AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY CAN INDICATE A DEVICE LOCKUP OR RESET. 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 21504831 ↗
• MalfunctionNov 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHUTTING DOWN UNEXPECTEDLY. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730590 ↗
• MalfunctionNov 5, 2024Failure 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 20610018 ↗
• MalfunctionOct 25, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT CONTROLS ON THEIR DEVICE ARE UNRESPONSIVE. 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 20533017 ↗
• MalfunctionOct 9, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT READING AN ECG SIGNAL THROUGH THE PADDLES LEAD AND DISPLAYED DASHED LINES. 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. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 20407745 ↗
• MalfunctionOct 6, 2024Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF MULTIPLE TIMES DURING A PATIENT EVENT. THEREAFTER, THE DEVICE WOULD NO LONGER POWER ON. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380009 ↗
• MalfunctionSep 17, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD UNEXPECTEDLY LOST POWER. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED.THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237600 ↗
• MalfunctionSep 13, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD UNEXPECTEDLY SHUT 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 20209837 ↗
• MalfunctionJul 1, 2024Failure to Power Up; Device Sensing Problem; Failure to Power Up; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON FURTHER EVALUATION OF THE DEVICE, STRYKER OBSERVED THAT THE DEVICE WOULD NOT POWER ON. IN THIS STATE, DEFIBRILLATION THERAPY WOULD 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 19641201 ↗
• MalfunctionJun 28, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE THERAPY CABLE WAS INTERMITTENTLY WORKING. 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 19631778 ↗
• MalfunctionJun 24, 2024Fracture; Fracture

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THE THERAPY CONNECTOR WAS CRACKED. 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 19601531 ↗
• MalfunctionJun 12, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED 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 19524833 ↗
• MalfunctionMar 21, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER. 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 18949735 ↗
• MalfunctionMar 18, 2024Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE DOES NOT BOOT UP INTO NORMAL OPERATION 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 18926801 ↗
• MalfunctionMar 12, 2024Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT DEFIBRILLATION CHARGE ON THEIR DEVICE IS INCOMPLETE. 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 18885536 ↗
• MalfunctionFeb 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR SCREEN WENT BLACK. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH MAY INDICATE A DEVICE LOCK UP. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744514 ↗