LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00883873987995), received between Dec 1, 2021 and Oct 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2022Failure to Power Up; Failure to Power Up

  STRYKER WAS PERFORMING PREVENTATIVE MAINTENANCE ON A CUSTOMER'S DEVICE AND OBSERVED THAT THE DEVICE IS NOT COMPLETING THE BOOT UP PROCESS. THE DEVICE IS LOCKING UP AT THE SELF TEST SCREEN. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546403 ↗
• MalfunctionDec 1, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S DISPLAY WENT BLANK WHILE TREATING A PATIENT. 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. THE CUSTOMER REPORTED THE USER WAS ABLE TO USE A BACKUP MONITOR WITHOUT FURTHER INCIDENT DURING THE PATIENT EVENT.

  Patient problems: Arrhythmia

  MAUDE report 12910843 ↗