BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 702637 · Received October 13, 2005

    Report

    Report Number
    1039368-2005-00001
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Date of Event
    September 16, 2005
    Report Date
    September 16, 2005
    Manufacturer
    WITT BIOMEDICAL CORP
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MONITOR CAME OFF BOOM (SLIDING MOTION) PRIOR TO CASE STARTING AND NURSE CAUGHT THE MONITOR. NO INJURIES TO PT. NURSE WILL GO TO EMPLOYEE HEALTH TO HAVE SHOULDER LOOKED AT. REVIEW OF OUR RECORDS SHOWS THAT THE CRT MONITOR WAS ORIGINALLY INSTALLED ON 08/2000 AND REMOUNTED ON 04/2002. THE HARDWARE SERVICE MANUAL FOR THE WITT BIOMEDICAL SERIES IV SYSTEM, PAGE 6-45 (REV.8) STATES "CONFIRM BOOM MONITOR MOUNTING INTEGRITY" AS A MONTLY PREVENTIVE MAINTENANCE REQUIREMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *