LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00883873979419), received between Sep 5, 2018 and Oct 25, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON SOMETIMES DOESN'T FUNCTION. AS A RESULT, THE DEVICE MAY NOT BE ABLE TO POWER ON TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12690019 ↗
• MalfunctionNov 12, 2020Failure to Analyze Signal; Failure to Analyze Signal

  A PHYSIO-CONTROL SERVICE REPRESENTATIVE WAS PERFORMING A TECHNICAL SERVICE UPDATE ON THE CUSTOMER¿S DEVICE AND OBSERVED AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10830251 ↗
• MalfunctionJan 7, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE TURNED OFF TWICE DURING A CALL. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558877 ↗
• MalfunctionNov 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IT LOCKED UP AND THE SERVICE INDICATOR WAS ILLUMINATED. 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 9371944 ↗
• MalfunctionAug 27, 2019Failure to Power Up; Application Program Freezes or Fails to Launch; Failure to Power Up; Application Program Freezes or Fails to Launch

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FREEZES AT THE SELF-TEST START UP MENU. 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 8935580 ↗
• MalfunctionApr 8, 2019Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND AN EVENT CODE IN ITS MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE AND, AS A RESULT, THE UNIT MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8491625 ↗
• MalfunctionOct 23, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY WOULD NOT POWER ON OR OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7997274 ↗
• MalfunctionOct 10, 2018Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED "ABNORMAL ENERGY DELIVERED". AS A RESULT, THE WRONG DEFIBRILLATION OR NO DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7951436 ↗
• MalfunctionSep 5, 2018Failure to Deliver Shock/Stimulation; Failure to Deliver Energy; Failure to Deliver Shock/Stimulation; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD FAILED A USER TEST. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY.

  Patient problems: No Patient Involvement

  MAUDE report 7848483 ↗