BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3820994 · Received May 20, 2014

    Report

    Report Number
    3015876-2014-00566
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FERRITE BEAD FROM AN INTERNAL WIRE HARNESS WHICH WAS PUSHING DOWN ON AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U1 FROM THE ANALOG PCB ASSEMBLY. THE EXTRA PRESSURE PUT ON THE IC CHIP LED TO A BROKEN SOLDER JOINT BETWEEN U1 AND THE ANALOG PCB ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE SERVICE WRENCH ICON WAS ILLUMINATED ON THEIR DEVICE. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE LOGGED SEVERAL EVENT CODES AND WAS ONLY ABLE TO DELIVER THE NEGATIVE PORTION OF THE BIPHASIC DEFIBRILLATION SHOCK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299922 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1