LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001945)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00883873871812), received between Aug 10, 2018 and Jul 9, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (4 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.

• MalfunctionJul 9, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF DURING A PATIENT INVOLVED EVENT. 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 19699247 ↗
• MalfunctionApr 11, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087450 ↗
• MalfunctionMar 11, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873785 ↗
• MalfunctionJul 11, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEVICE FAILED ITS SYNC TEST WHEN ATTEMPTED. AS A RESULT, THERE WOULD HAVE BEEN A DELAY >30 SECONDS AND DEFIBRILLATION THERAPY WOULD BE DELIVERED IN THE WRONG TIME, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299802 ↗
• MalfunctionSep 30, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE A BOOT CYCLE. THE CUSTOMER ADVISED THAT UPON POWER ON THE DEVICE DISPLAY TURNED ON AND OFF MULTIPLE TIMES. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY 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 15510478 ↗
• MalfunctionMar 18, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FROZE WHILE DELIVERING ENERGY SHOCK, UNIT SCREEN FROZE AND WAS UNABLE TO SHOCK. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER REPORTED THE USER WAS ABLE TO POWER CYCLE THE DEVICE AND USE IT WITHOUT FURTHER INCIDENT DURING THE PATIENT EVENT.

  Patient problems: Arrhythmia

  MAUDE report 11521490 ↗
• MalfunctionDec 16, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT SHOCK DURING A CODE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER STATED THEY USED A DIFFERENT DEFIB DURING THE PROCEDURE, SO THERE WERE NO ADVERSE CONSEQUENCES. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL 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.

  Patient problems: Cardiac Arrest

  MAUDE report 11020601 ↗
• MalfunctionSep 1, 2020Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS CHARGED TO 360J AND THEN IT DROPPED THE CHARGE 1/2 WAY THROUGH. IT WAS REPORTED THAT CAREGIVERS HAD TO HIT CHARGE AGAIN THEN. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10476617 ↗
• MalfunctionApr 23, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE TESTING THIS DEVICE AND IT WAS CONTINUOUSLY REBOOTING ITSELF DURING THE SELF TEST PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9993578 ↗
• MalfunctionFeb 7, 2020Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO COMPLETE A DEFIBRILLATION CHARGE CYCLE WHEN PROMPTED ON MULTIPLE OCCASIONS. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9684651 ↗
• MalfunctionNov 26, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE DOES NOT DELIVER ANY DEFIBRILLATION ENERGY WHEN SHOCKING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 9380466 ↗
• MalfunctionNov 15, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYS A WHITE SCREEN AFTER TURNING ON, FLICKERS, AND THEN SHUTS OFF. THEY STATED THAT AFTER IT SHUTS OFF, THE AC POWER AND BATTERY LIGHTS ARE BOTH ILLUMINATED GREEN. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9329699 ↗
• MalfunctionNov 13, 2019Aborted Charge; Aborted Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE ABORTED THE CHARGE PRIOR TO THERAPY BEING DELIVERED. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION ENERGY TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9316442 ↗
• MalfunctionJul 26, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED AN EVENT CODE IN THE DEVICES MEMORY. THE EVENT CODE LOGGED IN ITS MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A FAILURE OF THE DEVICE TO CHARGE FOR DEFIBRILLATION. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. THE CUSTOMER ADVISED PHYSIO- CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834310 ↗
• MalfunctionOct 4, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S DISPLAY WILL FLICKER FOR A COUPLE OF SECONDS AND THEN GO OFF. WHEN THIS OCCURS THE DEVICE'S POWER INDICATOR IS STILL ILLUMINATED. THIS CAN BE INDICATIVE OF A DEVICE LOCK-UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT IS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7935206 ↗
• MalfunctionAug 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED ON WITH A FLICKERING DISPLAY, THEN THE DISPLAY WENT BLANK. WHEN THIS OCCURRED THE LEDS ON THE DEVICE WOULD ILLUMINATE BUT THE DISPLAY WOULD NOT TURN ON. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND 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 7773319 ↗