BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3241995 · Received July 23, 2013

    Report

    Report Number
    3015876-2013-00644
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO PHYSIO-CONTROL FAILURE ANALYSIS CENTER FOR FURTHER EVALUATION AND VERIFIED THE POWER ON FAILURE. PHYSIO-CONTROL OBSERVED THAT THE SERVICE WRENCH AND EMPTY BATTERY ICONS WERE DISPLAYED IN THE READINESS INDICATOR DUE TO A DEPLETED BATTERY. THE BATTERY WAS ALSO FURTHER EVALUATED AND NO DISCREPANCY WAS FOUND. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE FAILURE. IT WAS OBSERVED THAT THE DEVICE'S BATTERY WAS DISCHARGED AND THAT THE DEVICE FUNCTIONED WITH A NEW BATTERY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE UNDER WARRANTY. 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A USER TEST THE DEVICE HAD THE SERVICE WRENCH ICON ILLUMINATED IN THE READINESS DISPLAY. THEN FURTHER TO EVALUATION. IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON AND WOULD NOT SHOW ANY ICON IN THE READINESS DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343708 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1