LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001263)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00883873911556), received between Dec 20, 2018 and Mar 30, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE HAD A SHUT DOWN EVENT.THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727689 ↗
• MalfunctionMar 21, 2025Failure to Analyze Signal; Failure to Analyze Signal

  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 DEVICE'S AED FUNCTION BEING INOPERATIVE ALONG WITH PADDLES ECG. 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 21660828 ↗
• MalfunctionOct 24, 2023Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD UNEXPECTEDLY REBOOT DURING ROUTINE INSPECTION. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993736 ↗
• MalfunctionJun 13, 2022Charging Problem; Charging Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO COMPLETE A CHARGE FOR DEFIBRILLATION. AS A RESULT DEFIBRILLATION THERAPY WOULD BE 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 14676312 ↗
• MalfunctionJun 13, 2022Charging Problem; Charging Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO COMPLETE A CHARGE FOR DEFIBRILLATION. AS A RESULT DEFIBRILLATION THERAPY WOULD BE 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 14676284 ↗
• MalfunctionDec 7, 2021Failure to Power Up; Failure to Power Up

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954951 ↗
• MalfunctionSep 21, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN. 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 12508634 ↗
• MalfunctionFeb 15, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHUT OFF ON IT'S OWN 3 TIMES. 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 11330165 ↗
• MalfunctionFeb 15, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS CONSTANTLY REBOOTING ITSELF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327815 ↗
• MalfunctionFeb 12, 2021Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322072 ↗
• MalfunctionDec 8, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHUT OFF UNEXPECTEDLY. 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 10971176 ↗
• MalfunctionJul 13, 2020Failure to Deliver Energy; Failure to Deliver Energy

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

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

  MAUDE report 10268208 ↗
• MalfunctionMay 1, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE REBOOTED EVERY TIME THE PRINT BUTTON OR CODE SUMMARY BUTTONS WERE PRESSED. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO DETERMINE THE CORRECT HEART RHYTHM DUE TO CYCLING POWER. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. IT WAS REPORTED AT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED LATER IN DAY AND REFERRED TO PCP WITH PERICARDITIS. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10019412 ↗
• MalfunctionMay 1, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY REBOOTED ITSELF MULTIPLE TIMES WHILE THEY WERE USING IT ON A PATIENT. THE DEVICE WOULD REBOOT WHEN THEY PRESSED THE PRINT OR CODE SUMMARY BUTTONS. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10018866 ↗
• MalfunctionApr 29, 2020Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. 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 Patient Involvement

  MAUDE report 10009578 ↗
• MalfunctionMar 12, 2020Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE GAVE THE "DISARMING" MESSAGE WHEN CALIBRATING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9826303 ↗
• MalfunctionOct 4, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF MULTIPLE TIMES UNEXPECTEDLY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158901 ↗
• MalfunctionJan 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property 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 Patient Involvement

  MAUDE report 8261960 ↗
• MalfunctionDec 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT AFTER DELIVERING ONE (1) SHOCK TO THE PATIENT THAT THEIR DEVICE'S DISPLAY WENT BLANK, WHILE THE LED'S ON THE MAIN KEYPAD REMAINED LIT. MEDICAL PERSONNEL HAD ADVISED THE BIOMED THAT THE DEVICE'S DISPLAY REMAINED BLANK UNTIL THEY REMOVED AND REINSTALLED BOTH BATTERIES, AFTER WHICH THE DEVICE POWERED ON AND PROPER OPERATION WAS OBSERVED. THE REPORTED DEVICE BEHAVIOR IS INDICATIVE OF A DEVICE LOCKUP CONDITION THAT COULD DELAY OR PREVENT DEFIBRILLATION. THE CUSTOMER ADVISED THAT THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD). MEDICAL PERSONNEL HAD REPORTED THAT THE IMPLANTABLE ICD SHOCKED THE PATIENT DURING THE EVENT, BUT COULD NOT RECALL HOW MANY TIMES. A BACKUP DEVICE WAS OBTAINED AND USED TO CONTINUE PATIENT CARE. THE CUSTOMER ADVISED THAT THE PATIENT SURVIVED THE EVENT AND THAT NO FURTHER INFORMATION ABOUT THE PATIENT WAS AVAILABLE. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8185453 ↗