BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-PB MOBILE BARRIERS

    MDR report key: 2485616 · Received March 6, 2012

    Report

    Report Number
    2485616
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 6, 2012
    Manufacturer
    FLUKE BIOMEDICAL (FORMERLY NUCLEAR ASSOCIATES)
    Product Code
    IWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING CORONARY ANGIOGRAPHY. THE ATTENDING PHYSICIAN WAS WALKING ACROSS THE PROCEDURE ROOM IN ORDER TO INSERT SOME DOCUMENTS INTO THE PATIENT'S CHART. SINCE FLUOROSCOPY WAS ONGOING, HE WAS MOVING THE MOBILE X-RAY SHIELD ACROSS THE ROOM SO THAT HE WOULD REMAIN BEHIND IT. JUST AFTER HE LET GO, THE UPPER PORTION OF THE WINDOW SNAPPED OFF JUST ABOVE THE VERTICAL MOUNTS ON BOTH SIDES. THE CRACKED EDGE WAS SMOOTH BUT NOT SHARP LIKE GLASS. THE PIECE THAT FELL TO THE FLOOR DID NOT SHATTER NOR STRIKE ANYONE OR ANYTHING THAT WOULD HAVE COMPROMISED THE PROCEDURE.STAFF FORTUNATELY SAVED THE TWO PARTS OF THE BROKEN WINDOW. IT'S MADE OF PLASTIC, NOT GLASS SO THE PART THAT FELL DIDN'T SHATTER. THE DEVICE IS CONSIDERED A RADIATION SAFETY DEVICE BY THE MANUFACTURER. MY OPINION IS THAT THERE WAS A NOTCH NEAR ONE OF THE SIDE SUPPORT CHANNELS AND THAT THE CONTINUED FLEXING AND HANDLING OF THE UNSUPPORTED UPPER PORTION OF THE WINDOW OVER A LONG PERIOD OF TIME RESULTED IN A CRACK GROWING FROM THE NOTCH UNTIL THIS CATASTROPHIC EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR-PB MOBILE BARRIERS SHIELD, X-RAY, MOBILE IWS FLUKE BIOMEDICAL (FORMERLY NUCLEAR ASSOCIATES) 56-604 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NO OTHER THERAPIES