BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1803528 · Received August 5, 2010

    Report

    Report Number
    3015876-2010-00889
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND RECOMMENDED PURCHASING A REPLACEMENT DEFIBRILLATOR. FOLLOW-UP WITH THE REPORTER CONFIRMED THAT THE DEVICE WAS REMOVED FROM SERVICE AND THE CUSTOMER WILL PURCHASE A REPLACEMENT DEFIBRILLATOR. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THEREFORE, FURTHER INVESTIGATION COULD NOT BE PERFORMED TO DETERMINE THE CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ALL THREE (ATTENTION, CHARGE PAK, AND WRENCH) ICONS ILLUMINATED. THE CUSTOMER REPLACED THE CHARGE-PAK (INTERNAL HLC BATTERY CHARGER) BUT THE DEVICE CONTINUED SHOWING ALL ICONS AND FAILED TO POWER ON. THERE WAS NO PATIENT 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