BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2143612 · Received June 3, 2011

    Report

    Report Number
    3015876-2011-00444
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THE PT WENT INTO A VENTRICULAR FIBRILLATION RHYTHM. THE HOSPITAL STAFF CHARGED THE DEVICE TO DELIVER A DEFIBRILLATION SHOCK; HOWEVER, UPON DELIVERY, THE DEVICE FAILED TO DELIVER THE SHOCK. THE STAFF DID TRY TO DELIVER THE SHOCKS A FEW MORE TIMES WITH NO SUCCESS. A BACK-UP DEVICE WAS BROUGHT IN AND WAS ABLE TO SUCCESSFULLY DELIVER A DEFIBRILLATION SHOCK TO THE PT. THE PT WAS CONVERTED TO A NORMAL SINUS RHYTHM THROUGH TREATMENT, AND NO ADVERSE EFFECTS WERE CAUSED TO THE PT.

    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 NA