BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 676089 · Received February 8, 2006

    Report

    Report Number
    1039368-2006-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2006
    Date of Event
    May 4, 2002
    Report Date
    February 8, 2006
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOOM MONITOR BROKE LOOSE AND FELL OFF BOOM WHEN DOCTOR PUSHED ON THE MONITOR. REVIEW OF CO RECORDS SHOWS THAT THE CRT MONITOR WAS ORIGINALLY INSTALLED IN 01/2000 AND REMOUNTED DIRECTLY TO THE BOOM ASSEMBLY IN 05/2002 FOLLOWING THE REPORT THAT IT FELL OFF THE BOOM ASSEMBLY. THE MONITOR AND MOUNT WERE INSPECTED ON SITE AND IT WAS DETERMINED BY A WITT FIELD SERVICE TECHNICIAN THAT THE BOOM MONITOR HAD BEEN MOUNTED WITH THE PLASTIC BASE. THE INCIDENT MONITOR WAS REPLACED WITH A NEW MONITOR THAT WAS BOUGHT LOCALLY BY THE WITT FIELD SERVIVE TECHNICIAN. THE NEW MONITOR WAS MOUNTED DIRECTLY TO THE BOOM ASSEMBLY PER THE RECALL RELATED TO MDR #1039368-2001-0001. WITT BIOMEDICAL IS REPORTING THIS INCIDENT EVEN THOUGH NO ADVERSE EVENT OCCURRED DUE TO THE POTENTIAL OF AN IMPROPERLY MOUNTED OR LOOSE BOOM MONITOR FALLING OFF THE MOUNT AND INJURING A PT OR USER, IF PRESENT.

    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 *