BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUCKYDIAGNOST

    MDR report key: 1994304 · Received January 14, 2011

    Report

    Report Number
    3003768251-2011-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    KPR
    PMA / PMN Number
    K945278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION REVEALED THAT DURING THE FIELD SERVICE ENGINEER VISIT, HE MOUNTS CHECKED THE SCREWS ON THE COVER OF LONGITUDINAL CARRIAGE AND NOTICED THEY HAD COME LOOSE. A NEW SCREW WAS INSERTED AND THE REST ON THE PANEL WERE TIGHTENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PROBLEM WITH A COVER AT THE CEILINA MOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCKYDIAGNOST KPR PHILIPS MEDICAL SYSTEMS DMC GMBH 704060

    Patients

    Seq Age Sex Outcome Treatment
    1