BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 1029663 · Received April 15, 2008

    Report

    Report Number
    MW5006271
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 14, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BANK OF 4 VIDEO MONITORS FELL FROM THE CEILING SUSPENSION DURING A CATH LAB PROCEDURE. THE MONITOR BANK DID NOT FALL ON THE PT. STAFF MEMBER WAS REPOSITIONING THE MONITORS AT THE TIME OF THE FALL. STAFF PARTIALLY CAUGHT THE SYSTEM AND GUIDED IT TOWARD THE FLOOR. POWER AND VIDEO CABLES KEPT THE MONITORS FROM HITTING THE FLOOR. THIS SYSTEM WEIGHS 200 LB'S OR MORE. IF IT HAD BEEN POSITIONED OVER THE PT AT THE TIME OF THE FALL, IT COULD HAVE CAUSED SERIOUS INJURY. PHILIPS MEDICAL IS AWARE OF THE INCIDENT AND WILL LOOK AT THE ENGINEERING OF THEIR MONITOR SUSPENSION. ALL OTHER ROOMS HAVE BEEN CHECKED TO ENSURE ALL BOLTS ARE TIGHT IN THE MONITOR BANKS. THIS IS AN ASSEMBLY THAT COMES READY MADE FROM THE FACTORY, SO LOCAL INSTALLATION TECHNIQUE IS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS ASSEMBLY FOR MONITORS IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA FD 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1