BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAC GENESYS

    MDR report key: 61256 · Received July 31, 1996

    Report

    Report Number
    61256
    Event Type
    Injury
    Date Received
    July 31, 1996
    Date of Event
    July 25, 1996
    Report Date
    July 30, 1996
    Manufacturer
    ADAC LABORATOERIES
    Product Code
    IYX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HYPERCALCEMIC, TERMINAL LUNG PT IN NUCLEAR MEDICINE DEPT ON TABLE FOR A LUNG SCAN. PT'S LEFT ARM ACROSS CHEST FOR LATERAL VIEW WHILE CAMERA ROTATED ON CIRCULAR GANTRY. DUE TO WEAK, EMACIATED CONDITION, PT'S ARM SLIPPED OFF ABDOMEN AND WATCH BECAME CAUGHT ON THE COUNTERWEIGHT COVER WHERE ENCASED CABLE ENTERS THE COVER. AS CAMERA ROTATED, THE COVER PULLED THE WATCH CAUSING THE LEFT FOREARM TO BEND AND BREAK. EMERGENCY STOP BUTTON PUSHED. GANTRY WAS MOVED IN OPPOSITE DIRECTION TO RELEASE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAC GENESYS CAMERA-COUNTERWEIGHT IYX ADAC LABORATOERIES 1357 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S CONTINUOUS HEPARIN INFUSION IN PERIPHERAL IV.| IN PERIPHERAL IV.