BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-PB MOBILE BARRIERS

    MDR report key: 2538070 · Received April 9, 2012

    Report

    Report Number
    2921581-2012-00001
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 26, 2012
    Manufacturer
    FLUKE BIOMEDICAL
    Product Code
    KPY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS MFG BY NUCLEAR ASSOCIATES WHO WAS SUBSEQUENTLY ACQUIRED BY FLUKE BIOMEDICAL. CUSTOMER HAS BEEN CONTACTED TO DETERMINE IF PRODUCT IS AVAILABLE FOR INVESTIGATION. NO RESPONSE RECEIVED AS OF APR 5, 2012. F/U REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS 11 YR OLD (B)(4) CLEAR PB MOBILE BARRIER BROKE DURING USE. COMPLAINT DESCRIPTION AS PROVIDED IN CUSTOMER SUPPLIED 3500A: "EVENT DESC: THE PT WAS UNDERGOING CORONARY ANGIOGRAPHY. THE ATTENDING PHYSICIAN WAS WALKING ACROSS THE PROCEDURE ROOM IN ORDER TO INSERT SOME DOCUMENTS INTO THE PT'S CHART. SINCE FLUOROSCOPY WAS ON GOING, 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 MFR." "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 KPY FLUKE BIOMEDICAL 56-604

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other