LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00883873911693), received between Apr 15, 2019 and Sep 30, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2024Class IIOpen, Classified

   Due to an out of tolerance tool being used on monitor/defibrillator systems.

   Z-0230-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

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.

• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952785 ↗
• MalfunctionApr 24, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904338 ↗
• MalfunctionNov 8, 2022Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S THERAPY CONNECTION WAS INTERMITTENT. 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 15754195 ↗
• MalfunctionNov 1, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708104 ↗
• MalfunctionJul 12, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. WHEN THE ON/OFF BUTTON IS PRESSED THE DEVICE'S SCREEN FLASHES AND THE DEVICE POWERS OFF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988446 ↗
• MalfunctionDec 6, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE BUTTONS ON THE MAIN KEYPAD OF THEIR DEVICE WAS NOT FUNCTIONING. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12944520 ↗
• MalfunctionAug 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION BY PHYSIO-CONTROL IT WAS OBSERVED THAT THE DEVICE WOULD NOT COMPLETE THE POWERING ON PROCESS. 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 12310814 ↗
• MalfunctionApr 14, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED AN ABNORMAL ENERGY DELIVERY MESSAGE WHEN TESTING THE DEFIBRILLATION FUNCTION. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9958213 ↗
• MalfunctionMar 4, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A PHYSIO-CONTROL SERVICE REPRESENTATIVE WAS PERFORMING A FIELD ACTION ON THE CUSTOMER¿S DEVICE AND OBSERVED THAT THE 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 9789168 ↗
• MalfunctionJan 16, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A BLANK SCREEN BLACK WITH NO SERVICE LIGHTS 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 Patient Involvement

  MAUDE report 9597444 ↗
• MalfunctionJan 8, 2020Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. 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 REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9566751 ↗
• MalfunctionNov 27, 2019Energy Output Problem; Energy Output Problem

  PHYSIO-CONTROL OBSERVED A NON-CRITICAL ISSUE ON A TRAINING DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE TRAINING DEVICE, PHYSIO-CONTROL OBSERVED FAILURE OF THE DEVICE TO DELIVER BIPHASIC SHOCK. THE DEVICE WOULD DELIVER MONOPHASIC SHOCK ONLY.

  Patient problems: No Patient Involvement

  MAUDE report 9387035 ↗
• MalfunctionJul 31, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF AND THEN POWERED ITSELF BACK ON 30 TO 45 SECONDS AFTER IT POWERED OFF WHILE BEING USED ON A 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 RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846127 ↗
• MalfunctionJun 4, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED ITSELF OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8667851 ↗
• MalfunctionMay 22, 2019Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOGGED NON-CRITICAL EVENT CODE DURING PREVENTATIVE MAINTENANCE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE CUSTOMER¿S DEVICE WAS UNABLE TO COMPLETE A CHARGE FOR DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8632128 ↗
• MalfunctionApr 15, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE TO MONITOR A PATIENT AND THE DEVICE KEPT CHARGING FOR ENERGY DELIVER ON ITS OWN WITHOUT ANY USER INTERACTION. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY. 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 8516447 ↗