BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WITT SERIES IV PHYSIOMONITORING SYSTEM

    MDR report key: 367900 · Received December 21, 2001

    Report

    Report Number
    1039368-2001-00002
    Event Type
    Injury
    Date Received
    December 21, 2001
    Date of Event
    October 12, 2001
    Report Date
    December 21, 2001
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    DRT
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONITOR CAME LOOSE FROM THE BOOM RAILS ATTACH IT TO THE SUPPORT AND FELL APPROXIMATELY THREE FEET AND STRUCK PT'S LEG. ATTENDING TECHNICIAN LESSENED THE IMPACT WHEN HE TRIED TO CATCH IT. THE INCIDENT BRUISED THE PT'S LEG BUT DID NOT BREAK THE SKIN OR ANY BONES. THE IMPROPER SCREWS USED TO ATTACH THE MONITOR WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58207 WITT SERIES IV PHYSIOMONITORING SYSTEM VIEWSONIC MONITOR DRT WITT BIOMEDICAL CORPORATION G810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other