BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLIMATOR

    MDR report key: 44570 · Received October 24, 1996

    Report

    Report Number
    MW1010148
    Event Type
    Malfunction
    Date Received
    October 24, 1996
    Date of Event
    October 5, 1996
    Report Date
    October 11, 1996
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Product Code
    KPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RADIOGRAPHER WAS MOVING THE X-RAY COLLIMATOR INTO PLACE TO PERFORM A STUDY WHEN THE COLLIMATOR FELL FROM THE TUBE SUPPORT, NARROWLY MISSING A PT. WHEN THE SVC REP ARRIVED ON 10/8/96, IT APPEARED THAT THE THREADS HOLDING THE SCREWS FOR THE COLLIMATOR WERE STRIPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLIMATOR COLLIMATOR KPW SIEMENS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other