LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001221)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00883873912126), received between Sep 7, 2018 and Oct 30, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Unexpected 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 DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429893 ↗
• MalfunctionOct 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOCKED UP DURING INTERVENTION ON A PATIENT. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214360 ↗
• MalfunctionJul 15, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THEIR DEVICE DURING A PATIENT EVENT AND IT WAS NOT SHOWING THE PATIENT'S ECG WITH THE DEFIBRILLATION ELECTRODES CONNECTED. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. 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 15031513 ↗
• MalfunctionApr 12, 2022Defibrillation/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 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 14080047 ↗
• MalfunctionDec 10, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE, IT WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION MAY BE DELAYED OR PREVENTED IF IT HAD BEEN NECESSARY. THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8148797 ↗
• MalfunctionSep 7, 2018Intermittent Loss of Power; Intermittent Loss of Power

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF WHILE ATTEMPTING TO CHARGE, IN ORDER TO SHOCK. THE CUSTOMER ADVISED THAT WHILE CHARGING THE DEVICE, ITS DISPLAY WENT BLANK. MEDICAL PERSONNEL THEN REBOOTED THE DEVICE AND IT FUNCTIONED NORMALLY WITH NO FURTHER DISCREPANCIES OBSERVED. THE REPORTER ADVISED THAT THE REPORTED ISSUE LED TO AN APPROXIMATELY FOUR (4) MINUTE DELAY IN PROVIDING CARE TO THE PATIENT; HOWEVER, THE PATIENT WAS TREATED SUCCESSFULLY. THE PATIENT, A (B)(6) MALE, WAS RECEIVING CORONARY ARTERY BYPASS GRAFT SURGERY WHEN THE REPORTED ISSUE OCCURRED. THE PATIENT SURVIVED THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857023 ↗