BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUGUTAKDIAGNOST CLASSIC, DUAL-DETECTOR

    MDR report key: 3979253 · Received July 17, 2014

    Report

    Report Number
    3003768251-2014-00010
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLASTIC HOOK JAMMED ON THE FOOT BOARD AND DID NOT CLICK INTO PLACE BY ITSELF. THE CUSTOMER WAS INFORMED VIA A FIELD SAFETY NOTE TO CHECK ALWAYS THE RIGHT POSITION OF THE HOOK AND THAT THE HOOK IS LOCKED. THE FIELD SERVICE ENGINEER CHECKED THE SYSTEM AND VERIFIED THAT THE FOOT PLATE CANNOT FALL DOWN, IF THE PLASTIC HOOK IS CLICKED FULLY INTO THE TRANSPORT POSITION, AS DESCRIBED IN THE FIELD SAFETY NOTE. THIS IS A KNOWN PROBLEM AND HAS RESULTED IN A CLASS 2 RECALL WHICH WAS REPORTED TO FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING MOVEMENT OF THE "PATIENT SUPPORT" WHICH IS USED FOR POSITIONING FOR STANDING PATIENTS WHILE A STITCHING EXAMINATION) THE PLASTIC HOOK HAS RELEASED AND THE FOOTBOARD DROPPED DOWN AND HIT FIRST AND SECOND TOE OF OPERATOR'S RIGHT FOOT. THE FOOT WAS ICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420269 DUGUTAKDIAGNOST CLASSIC, DUAL-DETECTOR MQB PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH 712052

    Patients

    Seq Age Sex Outcome Treatment
    1