BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2820887 · Received November 6, 2012

    Report

    Report Number
    3015876-2012-00823
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REMOVED THERAPY PCB ASSEMBLY DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE THE U35 IC CHIP, PINS FIVE AND EIGHT OF THE COMPONENT HAD COLD SOLDER JOINT.

    Description of Event or Problem · 1

    DURING DAILY INSPECTION, THE CUSTOMER FOUND THAT DEVICE HAD EVENT CODES LOGGED IN THE MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT COULD NOT PROVIDE DEFIBRILLATION THERAPY IN AED MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1