BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2841672 · Received November 21, 2012

    Report

    Report Number
    3015876-2012-00849
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 29, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF A CRYSTAL DESIGNATOR Y4 FROM THE DIGITAL PCB ASSEMBLY. THE Y4 CRYSTAL HAD INTERMITTENT OUTPUT, WHICH CAUSED THE DEVICE TO LOCK-UP AND DEPLETE THE BATTERY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING IT'S SERVICE WRENCH AND THE BATTERY WAS DEPLETED AFTER ONLY 4 MONTHS OF USE. THERE WAS NO REPORT OF EXTENDED USE OF THE DEVICE TO DEPLETE THE BATTERY THIS QUICKLY. AFTER AN EVALUATION OF THE DEVICE BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD ACTUALLY INTERMITTENTLY LOCK-UP AND THE BATTERY WOULD DEPLETE DUE TO THIS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1