LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00883873911457), received between Sep 16, 2018 and Jul 10, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. IN THIS STATE, THE DEVICE MAY BE UNABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287807 ↗
• MalfunctionMay 27, 2022Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE INTERMITTENTLY DISPLAYED "CONNECT ELECTRODES". WHEN THE DEVICE WAS ABLE TO CHARGE SUCCESSFULLY FOR DEFIBRILLATION, INTERMITTENTLY IT WAS DISARM ITSELF AND THE SHOCK WAS NOT DELIVERED. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. IN ADDITION IT WAS OBSERVED THAT ONE SHOCK WAS BELOW THE NORMAL TOLERANCE. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525174 ↗
• MalfunctionApr 25, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  DURING ROUTINE TESTING BY STRYKER THE CUSTOMER'S DEVICE FAILED TO DELIVER ENERGY. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192474 ↗
• MalfunctionNov 10, 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 REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10817686 ↗
• MalfunctionSep 17, 2019Failure to Deliver Shock/Stimulation; Unexpected Shutdown; Failure to Deliver Shock/Stimulation; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN AND FAILED TO PROVIDE DEFIBRILLATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9079803 ↗
• MalfunctionApr 11, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A THIRD PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT A CUSTOMER'S DEVICE LOCKED UP DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER ADVISED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8507128 ↗
• MalfunctionApr 11, 2019Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  A THIRD PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT A CUSTOMER'S LOCKED UP DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT AFTER CONNECTING THE 12 LEADS ECG, THE DEVICE FROZE. THEY ATTEMPTED TO POWER OFF THE DEVICE, HOWEVER NONE OF THE BUTTONS WERE RESPONDING. THE BATTERIES IN THE DEVICE WERE REMOVED AND REINSTALLED, HOWEVER THE DEVICE WAS UNABLE TO POWER ON. THE BATTERIES WERE AGAIN REMOVED AND REINSTALLED, THEY WAITED A FEW MINUTES AND THE DEVICE WAS ABLE TO POWER ON TO A NORMAL STATE. DURING THE TROUBLESHOOTING OF THE DEVICE, A BACKUP DEVICE WAS ALREADY ON THE SCENE AND WAS USED. THE DEVICE WAS USED FOR MONITORING THE PATIENT ONLY. THIS ISSUE IS PATIENT RELATED. THE CUSTOMER ADVISED THAT THE USE OF THE DEVICE DID NOT AFFECT PATIENT CARE. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER ADVISED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8507125 ↗
• MalfunctionApr 11, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A THIRD PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT A CUSTOMER'S DEVICE LOCKED UP DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER ADVISED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8507124 ↗
• MalfunctionApr 2, 2019Failure to Power Up; Failure to Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 8476492 ↗
• MalfunctionDec 6, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT ALWAYS POWER ON. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8137665 ↗
• MalfunctionSep 16, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT-UP PROCESS IN ORDER TO POWER ON. THE DEVICE WILL BEHAVE AS THOUGH IT'S ATTEMPTING TO POWER ON, BUT THEN IMMEDIATELY POWERS OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7879820 ↗