LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873911747), received between Apr 16, 2019 and May 9, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Energy Output Problem; Energy Output Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION TOLERANCE OF THEIR DEVICE WAS OUT OF RANGE. AS A RESULT, WRONG DEFIBRILLATION THERAPY WOULD HAVE BEEN PROVIDED, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898713 ↗
• MalfunctionJan 18, 2023Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THEIR DEVICE DURING A PATIENT EVENT AND IT WOULDN'T RECOGNIZE THE ATTACHED DEFIBRILLATION ELECTRODES. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, 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 16194812 ↗
• MalfunctionApr 16, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND ON BY ITSELF DURING A PATIENT EVENT. THIS ISSUE OCCURRED WHEN THE CUSTOMER PRESSED THE CODE SUMMARY BUTTON. THE PATIENT WAS BEING MONITORED ONLY. A BACKUP DEVICE WAS NOT AVAILABLE AND WAS NOT NECESSARY. THE CREW WAS ABLE TO CARE FOR THE PATIENT WITH THE DEVICE. THE ISSUE WITH THE DEVICE AFFECTED ONLY THE DOCUMENTATION BUT NOT THE PATIENT CARE. THE PATIENT, AN 87 YEAR OLD FEMALE WAS SUCCESSFULLY TRANSPORTED TO THE HOSPITAL. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER ADVISED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. THE PATIENT DID SURVIVE TO THE HOSPITAL, HOWEVER THE CUSTOMER DID NOT KNOW THE FINAL OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520962 ↗