BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 928767 · Received October 16, 2007

    Report

    Report Number
    3015876-2007-00416
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 24, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE. THE ROOT CAUSE HAS NOT BEEN DETERMINED. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DELIVER ENERGY WHEN TRYING TO CARDIOVERT A PT. THE DEVICE WAS POWERED FOR DELIVERY OF ENERGY FOUR TIMES BUT ONLY DELIVERED ENERGY 2 TIMES. THE PT WAS NOT INJURED AS A RESULT OF THE FAILURE TO DELIVER ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR