BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1060523 · Received June 11, 2008

    Report

    Report Number
    3015876-2008-00595
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL DEPARTMENT AND THE LOCAL PHYSIO-CONTROL SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND COULD NOT REPLICATE OR CONFIRM THE REPORTED PROBLEM. THE PHYSIO-CONTROL SERVICE REPRESENTATIVE ALSO OBSERVED PROPER DEVICE OPERATION THROUGH FULL FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    HOSPITAL PERSONNEL RESPONDED TO A PATIENT IN CARDIAC ARREST. ACCORDING TO THE REPORTER, THE DEVICE FAILED TO DELIVER ENERGY TO THE PATIENT X3. THE BASIS FOR THIS OPINION WAS NOT REPORTED. THE PATIENT WAS NOT RESUSCITATED. THE REPORTER INDICATED THAT USE OF THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH BECAUSE THE REPORTED EVENT MAY HAVE BEEN CAUSED BY A USE ERROR, NOT A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK