LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001264)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00883873911549), received between Jul 18, 2018 and May 13, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (15 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.

• MalfunctionMay 13, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHUT DOWN UNEXPECTEDLY. 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 22014294 ↗
• MalfunctionMar 20, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR 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 21652117 ↗
• MalfunctionSep 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHUT OFF UNEXPECTEDLY. 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 20257249 ↗
• MalfunctionJun 6, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNEXPECTEDLY SHUTTING DOWN. 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 19474847 ↗
• MalfunctionApr 9, 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. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069390 ↗
• MalfunctionFeb 5, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER. IN THIS STATE THE DEVICE WOULD 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 18647361 ↗
• MalfunctionFeb 5, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER. 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 18639507 ↗
• MalfunctionAug 10, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN UNEXPECTED LOSS OF POWER. 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 15199567 ↗
• MalfunctionJun 21, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT OFF. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760914 ↗
• MalfunctionDec 9, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN. 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 12973246 ↗
• MalfunctionJun 8, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS UNEXPECTEDLY POWERING ITSELF OFF AND ON. 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 11957897 ↗
• MalfunctionNov 11, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD DELIVER AN INACCURATE ENERGY LEVEL. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE OBSERVED CRITICAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10826877 ↗
• MalfunctionJan 9, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY TURN OFF AND WOULD TURN BACK ON WHEN THE 'ON' BUTTON WAS PRESSED. IN THIS STATE, THE DEVICE MAY CAUSE MORE THAN A 30 SECOND DELAY IN DELIVERING DEFIBRILLATION ENERGY. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568659 ↗
• MalfunctionDec 13, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTDOWN. IN THIS STATE THE DEVICE WOULD 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 9470148 ↗
• MalfunctionNov 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUTDOWN. 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 9282823 ↗
• MalfunctionOct 1, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY 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 ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9142659 ↗
• MalfunctionAug 30, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF WHILE PRINTING. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8950278 ↗
• MalfunctionMar 20, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS UNABLE TO COMPLETE THE BOOT-UP CYCLE IN ORDER TO POWER ON. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8438659 ↗
• MalfunctionJul 18, 2018Failure 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 7701283 ↗