BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112524 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00905
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 2, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED BY THE FAILURE ANALYSIS CENTER. THE REPORTED PROBLEM WAS VERIFIED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO A FAILURE OF THE BATTERY PACK ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE UNIT IS ALARMING LOW BATTERY AND NOT CHARGING THE BATTERY. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20E DEFIBRILLATOR/MONITOR MKJ PHYSIO-CONTROL, INC. 20E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA