BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 677918 · Received February 16, 2006

    Report

    Report Number
    1039368-2006-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2006
    Date of Event
    January 17, 2006
    Report Date
    January 17, 2006
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL IS UNDER CONSTRUCTION AND THEY HAVE INSTALLED A NEW ENTRY DOOR INTO THE SPECIAL LAB. THE NEW DOOR DOES NOT CLEAR THE CEILING MOUNTED BOOM MONITOR AND A STAFF MEMBER SLAMMED THE DOOR OPEN AND KNOCKED THE BOOM MONITOR OFF IT'S BRACKET STRIKING A STAFF MEMBER ON THE HEAD. THE STAFF MEMBER DID NOT WISH TO SEEK MEDICAL ATENTION AND PUT ICE ON HIS HEAD. THERE WAS NO PT IN THE ROOM AT THE TIME OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES IV PHYSIO-MONITORING SYSTEM BOOM MONITOR MWI WITT BIOMEDICAL CORPORATION VIEWSONIC G810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *