BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2544884 · Received April 18, 2012

    Report

    Report Number
    2544884
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 18, 2012
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIOLOGY TECHNOLOGISTS WERE PRESENT IN PATIENT'S ROOM FOR BILATERAL KNEE X-RAYS. NURSE WAS HOLDING THE PATIENT'S KNEE FOR THE X-RAY AND THE COLLIMATOR LIGHT EXPLODED ON THE PATIENT. EQUIPMENT HAS BEEN PULLED OFF UNIT. THE LIGHT IS USED TO ASSIST WITH POSITIONING AND TO ADJUST SIZE OF THE X-RAY FIELD. THERE WOULD BE NO INCREASE IN RADIATION EXPOSURE TO THE PATIENT AS A RESULTS OF THE COLLIMATOR BULB BURSTING.WE PURCHASED OUR SHIMADZU PORTABLE X-RAY MACHINES FROM A DEALER. THE DEALER SENT A SERVICE TECH TO CHECK THE MACHINE AND TRY TO DETERMINE THE REASON FOR THE BURSTING OF THE COLLIMATOR BULB. ALL OF HIS TESTS INDICATED THAT THE MACHINE IS OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. THE DEALER'S TECHNICIAN ASKED FOR, AND WE GAVE THEM, THE REMAINING PIECES OF THE BULB THAT WE HAD COLLECTED. THE DEALER AND SHIMADZU WANT TO ANALYZE THEM. AS A PRECAUTION, THE TECHNICIAN CHANGED THE COLLIMATOR BULBS ON OUR FIVE OTHER MACHINES THAT ARE OF THE SAME VINTAGE AS THE MACHINE IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * X-RAY SYSTEM, RADIOGRAPHIC, PORTABLE IZL SHIMADZU MEDICAL SYSTEMS 5037000027 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO