BEUDAMED
    FDA Adverse Event Summary report: N

    COLLIMATOR ACCESSORY LATCH

    MDR report key: 43973 · Received October 21, 1996

    Report

    Report Number
    MW1010122
    Date Received
    October 21, 1996
    Manufacturer
    MITSUBISHI INTL CORP.
    Product Code
    IYC
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COLLIMATOR ACCESSORY LATCH FAILED DURING GANTRY MOVEMENT CAUSING THE WEDGE MOUNT TRAY AND BLOCK MOUNT TRAY TO FALL TO THE FLOOR. A PT WAS ON THE TREATMENT TABLE AND THE TRAYS BARELY MISSED THE PT. A SVC BULLETIN WAS ISSUED BY MFR REGARDING A PROBLEM OF THIS NATURE. IT CALLS FOR THE PARTS TO BE INSPECTED AT THE TIME OF A PM AS A MINIMUM. A PM WAS DONE SEVEN DAYS PRIOR TO THIS INCIDENT. THIS BULLETIN WAS ISSUED 12/28/89 AND THERE HAS BEEN NO ATTEMPT THAT RPTR IS AWARE OF TO CORRECT THE DEFECT. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLIMATOR ACCESSORY LATCH COLLIMATOR IYC MITSUBISHI INTL CORP. EXL-8 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *