LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00883873871607), received between Mar 27, 2018 and Sep 26, 2024 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (9 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHUTTING OFF DURING OPERATION. 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 20307319 ↗
• MalfunctionJul 24, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. 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 19819418 ↗
• MalfunctionFeb 27, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE INTERMITTENTLY WOULD NOT TURN ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786711 ↗
• MalfunctionFeb 13, 2024Defibrillation/Stimulation Problem; Inappropriate or Unexpected Reset; Defibrillation/Stimulation Problem; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE POWERED OFF AFTER DISCHARGE TO PATIENT, AND AN EVENT CODE WAS OBSERVED 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 18695816 ↗
• MalfunctionDec 7, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD INTERMITTENT ISSUES POWERING UP. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288586 ↗
• MalfunctionOct 17, 2023Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT PROVIDE DEFIBRILLATION ENERGY. THIS ISSUE HAS THE POTENTIAL TO EITHER DELAY, OR PREVENT, DEFIBRILLATION FROM BEING DELIVERED. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952823 ↗
• MalfunctionOct 17, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A CUSTOMER HAS CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT DELIVERING ENERGY AS INTENDED. 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 17950675 ↗
• MalfunctionSep 29, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT COMPLETING THE BOOT-UP CYCLE. 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 17842638 ↗
• MalfunctionJun 30, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO PROVIDE DEFIBRILLATION THERAPY DURING INTERVENTION ON A PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238167 ↗
• MalfunctionApr 11, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710796 ↗
• MalfunctionMar 28, 2023Fracture; Fracture

  THE CUSTOMER CONTACTED STRYKER 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, STRYKER OBSERVED THAT 2 OF THE DEVICE'S BATTERY PINS WERE DAMAGED. AS A RESULT, THE DEVICE MAY UNEXPECTEDLY POWER OFF DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629356 ↗
• MalfunctionMar 13, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530876 ↗
• MalfunctionMar 13, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER 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 ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530457 ↗
• MalfunctionDec 16, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SHOCK BUTTON ON THEIR DEVICE WAS INTERMITTENT. THE CUSTOMER ADVISED THE BUTTON HAD TO BE PRESSED SEVERAL TIMES TO DELIVER THERAPY. IN THIS STATE DEFIBRILLATION THERAPY WOULD BE DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996815 ↗
• MalfunctionAug 23, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S KEYPAD IS NOT WORKING. 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 15280262 ↗
• MalfunctionJun 9, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR SERVICE INDICATOR IS ILLUMINATED. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. ANOTHER EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. ADDITIONALLY, THE DEFIBRILLATOR OUTPUT ENERGY MAY BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648469 ↗
• MalfunctionApr 29, 2022Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IS ASSOCIATED WITH 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 14253004 ↗
• MalfunctionMar 4, 2022Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD A CONNECTION ISSUE BETWEEN THE DEVICE AND THE DEFIBRILLATION THERAPY CABLE. AS A RESULT, THE DEVICE WAS UNABLE TO CHARGE FOR DEFIBRILLATION AND DELIVER ENERGY. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673738 ↗
• MalfunctionFeb 1, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate Waveform; Inappropriate/Inadequate Shock/Stimulation; Inappropriate Waveform

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED THE USER TEST AND LOGGED AN EVENT CODE IN THE DEVICE¿S MEMORY THAT IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. ADDITIONALLY, THE DEFIBRILLATOR OUTPUT ENERGY MAY BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE DISPLAYED AN ¿ABNORMAL ENERGY¿ MESSAGE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13409990 ↗
• MalfunctionNov 30, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD POWER OFF BY ITSELF WHEN THE CHARGE BUTTON WAS PRESSED. 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 12902597 ↗
• MalfunctionOct 15, 2021Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO RECOGNIZE WHEN THE ELECTRODES WERE CONNECTED TO THE PATIENT. 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 12643692 ↗
• MalfunctionOct 7, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT, "THIS UNIT WONT POWER ON". 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 12591668 ↗
• MalfunctionMay 3, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR IS PRESENT, TWO EVENT CODES ARE LOGGED IN THE MEMORY OF THEIR DEVICE, AND SHOCK WOULD NOT DELIVER. ONE EVENT CODE IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. THE OTHER EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE IS NO REPORT OF PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766883 ↗
• MalfunctionMar 1, 2021Failure to Power Up; Failure to Power Up

  DURING INVESTIGATION OF AN UNRELATED ISSUE, PHYSIO-CONTROL FOUND THAT THE DEVICE WOULD NOT TURN ON WHEN THE POWER BUTTON WAS PUSHED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391264 ↗
• MalfunctionFeb 12, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK DURING A PATIENT EVENT. A BACKUP DEVICE WAS AVAILABLE AND USED TO DELIVER A SHOCK TO THE PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322182 ↗