BEUDAMED
    FDA Adverse Event Summary report: N

    SIMULIX Y

    MDR report key: 12675 · Received April 11, 1994

    Report

    Report Number
    MW1001533
    Date Received
    April 11, 1994
    Date of Event
    March 28, 1994
    Report Date
    March 31, 1994
    Manufacturer
    OLDELFT CORP. OF AMERICA
    Product Code
    KPQ
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A FAULTY CHIP IN THE INFRARED REMOTE CONTROL CIRCUITRY CAUSED THE TABLE WITH A PT ON IT TO MOVE TOWARDS THE TUBE WHEN NO COMMAND WAS ACTIVATED. TABLE MOTION WAS STOPPED ONLY AFTER HITTING THE EMERGENCY STOP BUTTON. THE ANTI-COLLISION RING PROVIDED BY THE MFR ON THE COLLIMATION ASSEMBLY WOULD HAVE STOPPED THE MOTION ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMULIX Y KPQ OLDELFT CORP. OF AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 *