LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00883873872093), received between Oct 23, 2018 and Aug 12, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (6 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.

• MalfunctionAug 12, 2024Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT A SERVICE INDICATOR IS PRESENT AND EVENT CODES ARE LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODES INDICATE 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, AS WELL AS A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959087 ↗
• MalfunctionJul 1, 2024Defibrillation/Stimulation Problem; Key or Button Unresponsive/not Working; Defibrillation/Stimulation Problem; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE'S POWER BUTTON WAS FUNCTIONING INTERMITTENTLY. 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 19651990 ↗
• MalfunctionJun 14, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT 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 WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538274 ↗
• MalfunctionJun 6, 2024Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP CYCLE AND THE SCREEN REMAINED BLANK. 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 19475848 ↗
• MalfunctionFeb 14, 2024Defibrillation/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 18702273 ↗
• MalfunctionDec 15, 2023Defibrillation/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 DELIVERING ENERGY. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333644 ↗
• MalfunctionOct 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION STRYKER OBSERVED THAT THE DEVICE WILL NOT RECOGNIZE THERAPY CABLE. 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 18041067 ↗
• MalfunctionOct 17, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S MAIN KEYPAD IS NOT FUNCTIONING. IN THIS STATE, THE DEVICE MAY BE UNABLE 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 17947708 ↗
• MalfunctionOct 9, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE WOULD NOT ESCALATE TO APPROPRIATE DEFIBRILLATION ENERGY. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THIS ISSUE IS PATIENT-RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895656 ↗
• MalfunctionJan 4, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR SERVICE INDICATOR IS ILLUMINATED. 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. 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 INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099686 ↗
• MalfunctionOct 5, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. 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 15544510 ↗
• MalfunctionOct 28, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10753105 ↗
• MalfunctionOct 23, 2018Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS NOT SHOCKING PROPERLY DURING AN EVENT. THE CUSTOMER ADVISED THAT PERSONNEL ATTEMPTED TO CHANGE THE JOULES BUT THAT IT CONTINUED TO NOT WORK. THE CUSTOMER ADVISED THAT HE HAD NO FURTHER DETAILS ABOUT THE REPORTED ISSUE. THE CUSTOMER FURTHER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. A BACKUP DEVICE, ALSO A LIFEPAK 15, WAS AVAILABLE AND USED TO CONTINUE PATIENT CARE. THE CUSTOMER ADVISED THAT HE HAD NO FURTHER INFORMATION REGARDING THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7994870 ↗