BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1544876 · Received November 6, 2009

    Report

    Report Number
    3015876-2009-01629
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 7, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PHYSIO-CONTROL PROVIDED CUSTOMER TECHNICAL ASSISTANCE. FOLLOW UP WITH CUSTOMER FOUND THAT REPLACEMENT OF THE CHARGE PAK (INTERNAL BATTERY CHARGER) DID NOT RESOLVE THE ISSUE AND THE DEVICE WOULD NOT POWER ON. CUSTOMER HAS REMOVED THE DEVICE FROM SERVICE AND WILL BE PURCHASING A REPLACEMENT DEFIBRILLATOR. THE ROOT CAUSE OF THE MALFUNCTION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) ICONS ILLUMINATED. THE REPORTED SYMPTOM COULD BE AN INDICATIVE THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA