BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3790800 · Received May 5, 2014

    Report

    Report Number
    3015876-2014-00500
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS PERMANENTLY REMOVED THE DEVICE FROM USE AND WILL BE PURCHASING A REPLACEMENT DEVICE. THE DEVICE HAS NOT BEEN EVALUATED BY PHYSIO-CONTROL. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD BOOT UP TO SERVICE SCREEN WITH A CRITICAL EVENT CODE DISPLAYED. WITH THIS EVENT CODE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266776 LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1