BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAC TRANSCAM

    MDR report key: 1641320 · Received March 9, 2010

    Report

    Report Number
    1641320
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    TRANSCAM NUCLEAR MEDICINE CAMERA WAS BEING PREPPED TO BE USED. DURING PREP, THE TECH SAID THE DETECTOR SUDDENLY CAME FORWARD TOWARDS HIM AND FELL TO THE FLOOR. THREE OF THE RIGHT BOLTS HOLDING THE DETECTOR TO THE YOKE WERE BENT, BOLTS APPEARS TO HAVE PULLED THROUGH THREADS IN THE DETECTOR. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAC TRANSCAM NUCLEAR MEDICINE, GAMMA CAMERA IYX PHILIPS MEDICAL SYSTEMS PN 5200-2338 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR