BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3072977 · Received April 23, 2013

    Report

    Report Number
    3015876-2013-00327
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THAT THE DEVICE'S INTERNAL HLC BATTERIES WERE DEPLETED, BUT WAS UNABLE TO DETERMINE THE CAUSE OF THE DEPLETED HLC BATTERIES. IT WAS OBSERVED THAT THE CHARGE-PAK HAD BENT CONNECTOR PINS, BUT THIS DID NOT CONTRIBUTE TO THE DEPLETED INTERNAL HLC BATTERIES IN THE DEVICE. A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK), WHICH IS AN INDICATION THAT THE DEVICE WOULD NOT HAVE SUFFICIENT POWER TO PROVIDE DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174648 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1