LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873979105), received between Jul 1, 2019 and Nov 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT 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 12742243 ↗
• MalfunctionOct 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE BOOT UP PROCESS. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9211543 ↗
• MalfunctionJul 1, 2019Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE 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 Patient Involvement

  MAUDE report 8751043 ↗