BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN SERIES 777 INTEGRATED WALL SYSTEM

    MDR report key: 3961373 · Received May 30, 2014

    Report

    Report Number
    1316463-2014-00003
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 29, 2014
    Manufacturer
    WELCH ALLYN
    Product Code
    HMF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION AS IT IS UNCLEAR WHETHER THE DEVICE OR INCORRECT INSTALLATION OF THE DEVICE OR SOME OTHER FACTOR CAUSED THE EVENT. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    WELCH RECEIVED AN INITIAL REPORT FROM A FACILITY WITH AN ALLEGATION OF THE WALL TRANSFORMER SYSTEM, MOUNTED NEAR THE HEAD OF THE BED, HAD FALLEN OFF THE WALL. THE WEIGHT OF THE MOUNT CAUSED IT TO FALL FORWARD AND STRIKE A PT IN THE HEAD. THE PT PRESENTED WITH A MINOR SOFT TISSUE INJURY WITH NO FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318348 GREEN SERIES 777 INTEGRATED WALL SYSTEM WALL TRANSFORMER, 86H-MF HMF WELCH ALLYN 77710

    Patients

    Seq Age Sex Outcome Treatment
    1