BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKEYE VG

    MDR report key: 458002 · Received May 1, 2003

    Report

    Report Number
    9613299-2003-00003
    Event Type
    Malfunction
    Date Received
    May 1, 2003
    Date of Event
    December 3, 2002
    Report Date
    May 1, 2003
    Manufacturer
    ELGEMS, LTD.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO COLLIMATORS FELL OFF DURING COLLIMATOR EXCHANGE. WHILE THE HEADS WERE RETRACTING FOLLOWING A PRESUMED TRANSFER OF THE COLLIMATORS TO THE CART, THE COLLIMATORS BOTH FELL. THERE WAS SOME DAMAGE TO ONE OF THE HEADS. A ROOT CAUSE ANALYSIS FOUND THE LOCKER BARS ON THE HEAD TO BE IMPROPERLY ADJUSTED. THEY WERE TOO HIGH IN THE OPEN POSITION, THUS NOT ALLOWING FOR SMOOTH TRANSFER OF THE COLLIMATORS FROM THE HEADS TO THE CART. FMI 40752 HAD NOT BEEN IMPLEMENTED AT THIS SITE. THIS FMI ADDRESSES, AMONG OTHER THINGS, THE PROPER POSITIONING OF THOSE LOCKER BARS. PLANS ARE IN PLACE TO IMPLEMENT FMI 40752. NO INJURIES OR OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAWKEYE VG NUCLEAR MEDICINE KPS ELGEMS, LTD. ASM001092 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA