BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 4170396 · Received October 14, 2014

    Report

    Report Number
    3015876-2014-01215
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THEIR DEVICE IS NOT FIELD SERVICEABLE AND NO LONGER UNDER WARRANTY. IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THE DEVICE HAS BEEN PERMANENTLY REMOVED FROM SERVICE. 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 WHEN TESTING THEIR DEVICE NONE OF THE BUTTONS WERE RESPONSIVE EXCEPT THE POWER BUTTON. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651750 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1