BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST

    MDR report key: 3830778 · Received May 1, 2014

    Report

    Report Number
    3003768251-2014-00009
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL IMAGING SUPPORT TECHNOLOGIST RECOGNIZED AFTER RECEIVING THE FIELD SAFETY NOTE THAT THE PLASTIC HOOK JAMMED ON THE FOOT BOARD AND DOES NOT CLICK INTO PLACE BY ITSELF. THIS IS A KNOWN PROBLEM AND HAS RESULTED IN A CLASS 2 RECALL. THE CUSTOMER WAS INFORMED VIA THE FIELD SAFETY NOTE TO CHECK ALWAYS THE RIGHT POSITION OF THE HOOK AND THAT THE HOOK IS LOCKED. THE RECALL NUMBER WILL BE PROVIDED WHEN SUPPLIED TO PHILIPS. (B)(4).

    Description of Event or Problem · 1

    THE FIX CLAMP HOLDING THE FOOTBOARD FROM STITCHING PT SUPPORT IN THE UPRIGHT POSITION DOES NOT ALWAYS CLICK INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261188 DIGITALDIAGNOST MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712050

    Patients

    Seq Age Sex Outcome Treatment
    1