BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 758484 · Received October 21, 2005

    Report

    Report Number
    1039368-2005-00002
    Event Type
    Malfunction
    Date Received
    October 21, 2005
    Date of Event
    September 28, 2005
    Report Date
    September 28, 2005
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WITT FIELD SERVICE TECH WAS ON SITE AND IT WAS BROUGHT TO HIS ATTENTION THAT THE BOOM MONITOR ON THE LEFT (WHEN LOOKING AT THE MONITORS FROM THE FRONT) WAS LOOSE ON THE MOUNT. CUSTOMER HAS (2) WITT BOOM MONITORS ON THEIR X-RAY BOOM ASSEMBLY. BOTH MONITORS WERE REMOUNTED AND "L" BRACKETS WERE ADDED AS A REDUNDANT SAFETY FEATURE TO BOTH OF THE BOOM MONITORS. BOOM ASSEMBLY POSITION IS ADJUSTED HORIZONTALLY AND VERTICALLY TO FACILITATE VIEWING DURING THE CASE IN THE CATH LAB. MOVEMENT OF THE BOOM SHOULD BE FACILITATED BY USING THE BOOM HANDLES PROVIDED BY THE BOOM MANUFACTURER. MOVEMENT THOUGH, OFTEN OCCURS BY PUSHING ON THE MONITOR. THIS PRACTICE PLACES STRESS ON THE MATING SURFACES, IN THIS CASE, A PLASTIC MONITOR CASING AND METAL MOUNT FITTINGS/SNAPS HOLDING THE MONITOR IN PLACE. THE HARDWARE SERVICE MANUAL FOR THE WITT BIOMEDICAL SERIES IV SYSTEM, PAGE 6-45 (REV.8) STATES "CONFIRM BOOM MONITOR MOUNTING INTEGRITY" AS A MONTHLY PREVENTIVE MAINTENANCE REQUIREMENT. WEAR SHOULD HAVE BEEN DETECTED DURING THESE CHECKS. WITT BIOMEDICAL WILL SURVEY OTHER SITES WITH THIS TYPE OF SETUP AND IS PLANNING TO IMPLEMENT REDUNDANT SAFETY FEATURES ON BOOM MONITORS INSTALLED ON MOUNTING PLATES. NO ACTIONS HAVE BEEN DEEMED NECESSARY FOR BOOM MONITORS MOUNTED DIRECTLY TO THE BOOM AS HAS BEEN THE PRACTICE SINCE 2002.

    Description of Event or Problem · 1

    WITT FIELD SERVICE TECH WAS ON SITE AND IT WAS BROUGHT TO HIS ATTENTION THAT THE BOOM MONITOR ON THE LEFT (WHEN LOOKING AT THE MONITORS FROM THNE FRONG) WAS LOOSE ON THE MOUNT. WITT BIOMEDICAL IS REPORTING THIS INCIDENT EVEN THOUGH NO ADVERSE EVENT OCCURRED DUE TO THE POTENTIAL OF AN IMPROPELY MOUNTED OR LOOSE BOOM MONITOR FALLING OFF THE MOUNT AND INJURING A PATIENT OR USER, IF PRESENT. REVIEW OF OUR RECORDS SHOWS THAT THE CRT MONITOR WAS ORIGINALLY INSTALLED ON 04/03/2001 AND REMOUNTED ON 04/23/2002. THE HARDWARE SERVICE MANUAL FOR THE WITT BIOMEDICAL SERIES IV SYSTEM. PAGE 6-45 (REV/ 8) STATES "CONFIRM BOOM MONITOR MOUNTING INTEGRITY" AS A MONTHLY 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 CORPORATION VIEWSONIC PF815 NA

    Patients

    Seq Age Sex Outcome Treatment
    1