LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001946)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00883873871805), received between Sep 14, 2018 and Dec 12, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD POWERED OFF DURING USE. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790609 ↗
• MalfunctionFeb 12, 2024Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT CYCLE DURING INITIAL POWER-UP. IN ADDITION, THE CUSTOMER NOTICED THAT THE DEVICE WOULD NO LONGER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18684371 ↗
• MalfunctionSep 29, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. 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 17848591 ↗
• MalfunctionJul 25, 2023Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE CUSTOMER¿S DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY. IN ADDITION AN EVENT CODE WAS LOGGED IN THE DEVICE'S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. STRYKER ALSO OBSERVED ANOTHER EVENT CODE LOGGED 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. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390457 ↗
• MalfunctionApr 24, 2023Failure to Deliver Shock/Stimulation; Impedance Problem; Failure to Deliver Shock/Stimulation; Impedance Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT AN OBSERVED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16793139 ↗
• MalfunctionJan 26, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250692 ↗
• MalfunctionApr 4, 2022Failure to Deliver Energy; Energy Output Problem; Failure to Deliver Energy; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYED AN "ABNORMAL ENERGY DELIVERED" MESSAGE DURING A PATIENT EVENT. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY HAVE BEEN DELIVERED TO THE PATIENT, IF NEEDED. 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, STRYKER OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS ALSO AN EVENT CODE LOGGED 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 NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000909 ↗
• MalfunctionApr 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT WOULD NOT COMPLETE A BOOT CYCLE. 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 13972650 ↗
• MalfunctionFeb 8, 2022Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Inappropriate Waveform; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Inappropriate Waveform

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DISPLAYS "ABNORMAL ENERGY DELIVERY MESSAGE." IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO THE PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE CUSTOMER¿S DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY. IN ADDITION, THE DEVICE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483244 ↗
• MalfunctionJan 4, 2022Failure to Deliver Energy; Energy Output Problem; Failure to Deliver Energy; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD EVENT CODE LOGGED IN ITS MEMORY AND GAVE AN "ABNORMAL ENERGY DELIVERY" MESSAGE. THE FIRST EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THE SECOND 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 REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158856 ↗
• MalfunctionFeb 26, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT 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. THEY ALSO REPORTED ANOTHER EVENT CODE LOGGED 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. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9759526 ↗
• MalfunctionJun 27, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8741565 ↗
• MalfunctionSep 14, 2018Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT SHOCK DURING A CARDIAC ARREST CALL. THE CUSTOMER ADVISED THAT THE DEVICE WOULD NOT SHOCK DURING TWO (2) ATTEMPTS. MEDICAL PERSONNEL HAD TO CALL FOR A BACKUP DEVICE. ONCE THE BACKUP DEVICE ARRIVED, IT WAS CONNECTED TO THE PATIENT TO CONTINUE CARE. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE, AS THE BACKUP DEVICE WAS USED TO CONTINUE PATIENT CARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7879353 ↗