BEUDAMED
    FDA Adverse Event Other Summary report: N

    EUREKA LINEAR IIIP

    MDR report key: 168953 · Received May 21, 1998

    Report

    Report Number
    1423380-1998-00001
    Event Type
    Other
    Date Received
    May 21, 1998
    Date of Event
    April 1, 1998
    Report Date
    May 13, 1998
    Manufacturer
    PROGENY, INC.
    Product Code
    IZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE COLLIMATOR DISCONNECTED FROM THE X-RAY TUBE ASSEMBLY. THE COLLIMATOR IS ATTACHED TO THE X-RAY TUBE BY A COLLAR THAT LOCKS WITH A HINGED LOCKING MECHANISM. THE COLLAR HAS A SAFETY CATCH THAT IS ATTACHED BY A CAP SCREW AT THE TIME OF INSTALLATION. THE THREADS OF THE SCREW HAVE VIBRATITE, A REUSABLE THREAD LOCKING PRODUCT, APPLIED TO PREVENT THE SCREW FROM BACKING OUT DUE TO VIBRATION. THE PRODUCT IS SHIPPED WITH A RED WARNING NOTICE INSTRUCTING THE INSTALLER TO READ THE INSTALLATION INSTRUCTIONS. THESE INSTRUCTIONS DESCRIBE THE PROPER INSTALLATION OF THE SAFETY CATCH AND TO ONLY USE THE SCREW PROVIDED THAT HAS VIBRATITE. CO'S CONCLUSION IS THAT INSTALLER EITHER DID NOT INSTALL THE SAFETY CATCH PROPERLY OR USED THEIR OWN SCREW THAT DID NOT HAVE VIBRATITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUREKA LINEAR IIIP COLLIMATOR IZX PROGENY, INC. 93741 (PICKER MODEL NO.) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other