BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3447239 · Received November 4, 2013

    Report

    Report Number
    3015876-2013-00988
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 11, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    (CATALOG NUMBER) OF THE INITIAL MEDWATCH REPORT INDICATES: 3202359. (CATALOG NUMBER) OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 3200731.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U16, ON THE DIGITAL PCB ASSEMBLY. PHYSIO OBSERVED A RESISTIVE PATH BETWEEN LEGS 1 AND 6 OF IC CHIP U16.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON THE DISPLAY AND THAT THE UNIT WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566475 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1