LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00883873911730), received between Jun 4, 2018 and Aug 7, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Failure to Deliver Shock/Stimulation

  The customer contacted Stryker to report that their device did not shock. 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 50184195 ↗
• MalfunctionJun 2, 2026Key or Button Unresponsive/not Working

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE BUTTONS ON THEIR DEVICE WOULD NOT WORK EXCEPT FOR THE POWER ON BUTTON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364863 ↗
• MalfunctionJan 22, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SERVICE INDICATOR IS PRESENT AND AN EVENT CODE IS LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODE LOGGED IN ITS MEMORY INDICATES A POTENTIAL DEVICE LOCK UP. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146026 ↗
• MalfunctionNov 17, 2025Failure 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 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 23578057 ↗
• MalfunctionOct 31, 2025Failure to Deliver Shock/Stimulation; Aborted Charge; Failure to Deliver Shock/Stimulation; Aborted Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY DUMPED ENERGY. DURING EVALUATION IT WAS ALSO 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. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434082 ↗
• MalfunctionJul 7, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ON/OFF BUTTON ON THE KEYPAD OF THEIR DEVICE WAS INTERMITTENTLY RESPONSIVE. 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 22413987 ↗
• MalfunctionJun 24, 2025Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO CHARGE 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 22313601 ↗
• MalfunctionDec 13, 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 PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929809 ↗
• 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. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE. THE CUSTOMER CONFIRMED THAT THE DEVICE USE ¿DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094867 ↗
• MalfunctionFeb 27, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER A SHOCK DURING TESTING. 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 18786811 ↗
• MalfunctionDec 27, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S KEYPAD IS FREEZING UP AND INTERMITTENTLY NOT FUNCTIONING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR 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 16056841 ↗
• MalfunctionJun 29, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER A SHOCK DURING DEVICE PREVENTATIVE MAINTENANCE. 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 14852603 ↗
• MalfunctionJan 21, 2022Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT RECOGNIZE THE DEFIBRILLATION PADDLES. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN UNAVAILABLE, IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314842 ↗
• MalfunctionDec 28, 2021Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL SOMETIMES NOT DELIVER ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13096473 ↗
• MalfunctionMar 20, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN AFTER A POWER CYCLE. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9862622 ↗
• MalfunctionSep 3, 2019Failure to Deliver Energy; Failure to Deliver Energy

  PHYSIO-CONTROL WAS PERFORMING A FIELD ACTION WHEN AN EVENT CODE WAS NOTED. THE EVENT CODE LOGGED IN THE DEVICES MEMORY CAN BE INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8957732 ↗
• MalfunctionFeb 27, 2019Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING AN EVENT THEIR DEVICE WOULD INTERMITTENTLY NOT DETECT THE PATIENT VIA A QUIK COMBO THERAPY CABLE AND PHYSIO-BRAND THERAPY ELECTRODES. THE CUSTOMER ADVISED THAT MEDICAL PERSONNEL WERE ATTEMPTING TO SHOCK THE PATIENT WHEN THE REPORTED ISSUE WAS OBSERVED. MEDICAL PERSONNEL THEN MANIPULATED THE CABLE AND WERE ABLE TO OBTAIN A RHYTHM AND CONTINUE PATIENT CARE. A BACKUP DEVICE WAS AVAILABLE, BUT NOT USED DURING THE EVENT. NO FURTHER DETAILS WERE PROVIDED. THE INABILITY TO OBTAIN THE PATIENT'S RHYTHM DURING THE EVENT COULD DELAY OR PREVENT DEFIBRILLATION IF IT WERE NECESSARY. THE CUSTOMER ADVISED THAT THE PHYSIO-BRAND THERAPY ELECTRODES USED DURING THE EVENT WERE DISPOSED OF AND THEREFORE NOT AVAILABLE FOR EVALUATION. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS REQUESTED ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374677 ↗
• MalfunctionFeb 27, 2019Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING AN EVENT THEIR DEVICE WOULD INTERMITTENTLY NOT DETECT THE PATIENT VIA A QUIK COMBO THERAPY CABLE AND PHYSIO-BRAND THERAPY ELECTRODES. AS A RESULT, DEFIBRILLATION COULD HAVE BEEN DELAYED OR PREVENTED, IF IT WERE NECESSARY. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER ADVISED THAT THE PHYSIO-BRAND THERAPY ELECTRODES USED DURING THE EVENT WERE DISPOSED OF AND THEREFORE NOT AVAILABLE FOR EVALUATION. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. ADDITIONALLY, THE EXACT DATE OF THE REPORTED EVENT WAS NOT REPORTED. THE CUSTOMER ONLY ADVISED THAT THE EVENT OCCURRED "ABOUT 2-3 MONTHS AGO."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374610 ↗
• MalfunctionFeb 18, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT AFTER SUCCESSFULLY SHOCKING A PATIENT, THE DEVICE SHUTOFF. IT TOOK SEVERAL ATTEMPTS OF PRESSING THE POWER BUTTON IN ORDER TO POWER DEVICE BACK ON. THEY WERE ABLE TO POWER THEIR DEVICE BACK ON, HOWEVER , IT IS UNKNOWN WHAT THE DELAY WAS IN POWERING THE DEVICE BACK ON. A SECONDARY MONITOR WAS BEING USED ON THE PATIENT AND THEY WERE ABLE TO IMMEDIATELY READ THE PATIENT'S ECG THROUGH THAT MONITOR. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT. HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8347976 ↗
• MalfunctionJan 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWER ON/OFF BUTTON IS HARD TO ACTIVATE. AS A RESULT, DEFIBRILLATION MAY BE DELAYED OR PREVENTED IF IT HAD BEEN NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8269085 ↗
• MalfunctionJun 4, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND AN EVENT CODE IN ITS MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE AND, AS A RESULT, THE UNIT MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7567129 ↗