BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3102726 · Received May 9, 2013

    Report

    Report Number
    3015876-2013-00376
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 15, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CAUSE OF THE REPORTED FAILURE WAS OBSERVED TO BE THE SOLDER JOINTS ON LEGS 1 AND 16 OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U1 WERE BROKEN LOOSE FROM THE ANALOG PCB ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING ITS SERVICE INDICATOR AND LOGGED AN EVENT CODE. AFTER AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE DID NOT DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202927 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1