BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2870953 · Received December 12, 2012

    Report

    Report Number
    3015876-2012-00894
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND RECOMMENDED INSTALLING A NEW CHARGE PAK TO TROUBLE SHOOT THE PROBLEM OR PURCHASING A REPLACEMENT DEFIBRILLATOR.

    Description of Event or Problem · 1

    DURING TRAINING, THE CUSTOMER FOUND THAT THE DEVICE HAD NO VOICE PROMPTS AND WAS DISPLAYING THE BATTERY (CHARGE PAK) ICON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1