BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2800425 · Received October 22, 2012

    Report

    Report Number
    3015876-2012-00784
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A THERMALLY SENSITIVE INTEGRATED CIRCUIT CHIP, DESIGNATOR U23 FROM THE DIGITAL PCB ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE BATTERY AND SERVICE INDICATORS WERE ILLUMINATED ON THEIR DEVICE. THE CUSTOMER THEN REPORTED THAT AFTER REPLACEMENT OF THE BATTERY, THE DEVICE EMITTED A CONSTANT BEEPING TONE AND WAS EXHIBITING A LOCK UP CONDITION. 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