BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1070663 · Received July 2, 2008

    Report

    Report Number
    3015876-2008-00732
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED WHAT APPEARED TO BE EXTERNAL DAMAGE FROM ABUSE AND THAT THE SERVICE INDICATOR WAS ILLUMINATED, BUT COULD NOT REPLICATE OR CONFIRM THE REPORTED FAILURE. THE DEVICE WOULD NOT INTERFACE WITH A PC TO DOWNLOAD DATA FROM DEVICE MEMORY. PHYSIO OPENED THE DEVICE AND OBSERVED THAT SEVERAL INTERNAL ASSEMBLIES HAD SUSTAINED DAMAGE. THE CUSTOMER SUBSEQUENTLY DECLINED AN OFFER FROM PHYSIO-CONTROL TO REPAIR THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, INTERMITTENTLY, WHEN POWERING ON THE DEVICE, IT APPEARS TO NOT POWER UP OR POWER UP WITH A BLANK MONITOR SCREEN. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    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