LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00883873884348), received between Oct 10, 2018 and Aug 29, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO SENSE THE PATIENT'S LOAD. IN THIS STATE, THE DEVICE MAY BE UNABLE 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 17644456 ↗
• MalfunctionFeb 21, 2023Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF THE DEVICE DELIVERING A MONOPHASIC SHOCK. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414294 ↗
• MalfunctionFeb 15, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. STRYKER 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. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376858 ↗
• MalfunctionFeb 14, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE EXHIBITED OUT OF RANGE DEFIBRILLATION TOLERANCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375818 ↗
• MalfunctionFeb 8, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING THE EVALUATION, IT WAS FOUND THAT THE ANALYZE BUTTON INTERMITTENTLY STUCK AND WAS UNABLE TO RELEASE. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321167 ↗
• MalfunctionMay 10, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ON/OFF BUTTON WAS NOT WORKING. 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 THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347938 ↗
• MalfunctionMay 9, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN AFTER PUSHING THE SHOCK BUTTON. 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 14332757 ↗
• MalfunctionMar 27, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DOSE NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578976 ↗
• MalfunctionMar 2, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402012 ↗
• MalfunctionDec 8, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY DUMPED A SHOCK AND THEN WOULD NOT SHOCK. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN 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 10969293 ↗
• MalfunctionSep 30, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHUT DOWN UNEXPECTEDLY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610645 ↗
• MalfunctionMay 4, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SHOCK BUTTON ON THEIR DEVICE WAS INOPERABLE DURING PATIENT USE. THE CUSTOMER ADVISED THAT THE DEVICE DID NOT DELIVER THE SHOCK AFTER THE SHOCK BUTTON WAS PRESSED. ANOTHER DEVICE WAS USED TO CONTINUE PATIENT CARE. IN THIS STATE DEFIBRILLATION THERAPY WOULD BE UNAVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10022844 ↗
• MalfunctionDec 4, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE BOOT UP CYCLE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9411122 ↗
• MalfunctionAug 15, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF WHILE THEY WERE USING IT ON A PATIENT. THEY WERE ABLE TO POWER IT ON RIGHT AFTER AND CONTINUE USING IT ON THE PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO PATIENT INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896396 ↗
• MalfunctionJan 28, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTDOWN DURING PATIENT USE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED OR ARE AVAILABLE FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283599 ↗
• MalfunctionOct 10, 2018Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS INTERMITTENTLY 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. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN 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 7954022 ↗