BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2151377 · Received June 8, 2011

    Report

    Report Number
    3015876-2011-00458
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE EVENT DOWNLOAD AND VERIFIED OCCURRENCE OF TWO POWER LOSSES DURING THE EVENT. HOWEVER, PHYSIO WAS UNABLE TO DUPLICATE ANY POWER PROBLEMS AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WILL BE RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST POWER SEVERAL TIMES WHILE MONITORING A PT IN AN AMBULANCE. THE DEVICE WAS SUCCESSFULLY TURNED BACK AFTER EACH INSTANCE FOR CONTINUED DEVICE USE. THE DEVICE USE HAD NO ADVERSE EFFECT ON THE PT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES LDD PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK