LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001216)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00883873912805), received between Aug 15, 2018 and Sep 14, 2026 — classified as 1 death, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (15 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Failure to Charge

  The customer contacted Stryker to report that their device would not charge during a patient case. 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 50756462 ↗
• MalfunctionAug 18, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299071 ↗
• MalfunctionMay 28, 2026Failure to Deliver Shock/Stimulation

  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 TO 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 25318109 ↗
• MalfunctionOct 28, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL 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 23406194 ↗
• MalfunctionJul 25, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  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 TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609911 ↗
• MalfunctionApr 3, 2025Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY DURING A PATIENT EVENT. THE DEVICE WAS ABLE TO CHARGE TO 200J SUCCESSFULLY. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769849 ↗
• MalfunctionJan 31, 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 21282382 ↗
• MalfunctionAug 28, 2024Failure to Analyze Signal; Device Sensing Problem; Failure to Analyze Signal; Device Sensing Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083846 ↗
• MalfunctionAug 22, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE DELIVERED DEFIBRILLATION AT AN UNEXPECTED LEVEL. IN THIS STATE THE DEVICE MAY DELIVER INAPPROPRIATE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17593083 ↗
• MalfunctionMar 13, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER A SHOCK WHEN USING INTERNAL PADDLES DURING A PATIENT EVENT. THE CUSTOMER USED EXTERNAL PADDLES AS THE BACKUP PROCEDURE. 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 16530708 ↗
• MalfunctionJan 10, 2023Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S SERVICE INDICATOR IS ILLUMINATED AND THERE WAS AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132497 ↗
• MalfunctionNov 30, 2022Failure to Deliver Shock/Stimulation; Key or Button Unresponsive/not Working; Failure to Deliver Shock/Stimulation; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT PROVIDE A SHOCK WHEN THE SHOCK BUTTON WAS PRESSED. 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 15890650 ↗
• MalfunctionJul 15, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT POWERING 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 15026690 ↗
• DeathNov 2, 2021Failure to Deliver Shock/Stimulation; Unexpected Shutdown; Failure to Deliver Shock/Stimulation; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND WHEN THEY PRESSED THE DEVICE'S SHOCK BUTTON TO DELIVER A SHOCK TO THE PATIENT, THE DEVICE UNEXPECTEDLY POWERED OFF AND THEN POWER CYCLED. AS A RESULT, DEFIBRILLATION THERAPY WAS DELAYED. THE CUSTOMER INFORMED PHYSIO-CONTROL THAT THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739139 ↗
• MalfunctionJun 14, 2021Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE POWER PORT ON THE BACK OF THEIR DEVICE IS BROKEN AND THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995452 ↗
• MalfunctionMay 28, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING TESTING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901046 ↗
• MalfunctionMay 4, 2021Failure to Power Up; Failure to Power Up

  PHYSIO-CONTROL RECEIVED A REPORT THAT "ON/OFF BUTTON NOT RESPONDING". IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE IS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771298 ↗
• MalfunctionMar 8, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441094 ↗
• MalfunctionMar 3, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK TO A PATIENT WHEN THE USER PRESSED THE SHOCK BUTTON. THE SHOCK BUTTON WAS PRESSED A SECOND TIME AND THEN A SHOCK WAS SUCCESSFULLY DELIVERED TO THE PATIENT. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF NEEDED. 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 11408355 ↗
• MalfunctionFeb 17, 2021Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338394 ↗
• MalfunctionDec 8, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTDOWN, AND DISPLAYED A SERVICE CODE. THE SERVICE CODE MAY BE INDICATIVE OF 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 10970088 ↗
• MalfunctionNov 6, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S BUTTONS ARE NOT FUNCTIONING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10801914 ↗
• MalfunctionJun 22, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10182578 ↗
• MalfunctionJun 16, 2020Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE ON/OFF BUTTON OF THEIR DEVICE WAS DIFFICULT TO ACTIVATE. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THE ON/OFF BUTTON WAS INOPERABLE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156372 ↗
• MalfunctionMay 13, 2020Failure to Deliver Shock/Stimulation; Display or Visual Feedback Problem; Failure to Deliver Shock/Stimulation; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER SHOCK AND THE ECG WAS NOT VISIBLE ON THE SCREEN. DEFIBRILLATION WAS AGAIN ATTEMPTED AND WAS SUCCESSFUL, AND ROSC WAS OBTAINED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. THE REPORTER STATED AN INTERNAL INVESTIGATION IS ONGOING AS USE ERROR IS THE SUSPECTED CAUSE OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053835 ↗