BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITT BIOMEDICAL SERIES IV SYSTEM

    MDR report key: 338325 · Received June 15, 2001

    Report

    Report Number
    1039368-2001-00001
    Event Type
    Malfunction
    Date Received
    June 15, 2001
    Date of Event
    May 17, 2001
    Report Date
    June 12, 2001
    Manufacturer
    WITT BIOMEDICAL CORP.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE PUSHED ON THE BACK OF THE HANGING BOOM TO MOVE THE MONITORS CLOSER TO THE PATIENT AND WHEN THE NURSE STOPPED THE BOOM, THE MONITOR DISLODGED FROM ITS SWIVEL BASE AND FELL TO THE FLOOR NEAR THE PATIENT. IT WAS THOUGHT TO HAVE BRUSHED THE PT'S LEG WHEN FALLING. THE PT EXPRESSED ON INJURY FROM THE MONITOR INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27471 WITT BIOMEDICAL SERIES IV SYSTEM PHYSIOMOITORING SYSTEM VIDEO MONITOR MOUNTED ON SUSPENSION MWI WITT BIOMEDICAL CORP. 17" VIEWSONIC VIDEO MONITOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other