BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    767 INTEGRATED DIAGNOSTIC WALL SYSTEM

    MDR report key: 4063420 · Received July 8, 2014

    Report

    Report Number
    1316463-2014-00004
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 8, 2014
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    GCW
    PMA / PMN Number
    K771864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION PENDING COMPLETION OF THE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    WELCH ALLYN RECEIVED AN INITIAL REPORT FROM A FACILITY WITH AN ALLEGATION THAT THE WALL TRANSFORMER SYSTEM, MOUNTED OVER THE BED, HAD BEEN KICKED UPWARD AT THE BASE DISLODGING IT FROM THE WALL MOUNT. THE DEVICE HIT THE PATIENT'S FATHER, BUT DID NOT INJURE HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398868 767 INTEGRATED DIAGNOSTIC WALL SYSTEM WALL TRANSFORMER GCW WELCH ALLYN, INC. 76792-M

    Patients

    Seq Age Sex Outcome Treatment
    1