BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUINSA

    MDR report key: 1439060 · Received May 7, 2009

    Report

    Report Number
    1000404222-2009-0001
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    April 7, 2009
    Manufacturer
    SUINSA
    Product Code
    IZO
    PMA / PMN Number
    K083109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS LYING ON THE TABLE WHILE TECHNICIANS WERE IN THE CONTROL BOOTH ADJUSTING AN IMAGE SIZE (ON THE CANON SYSTEM) TO SEND TO THE PRINTER. THE ELITE SYSTEM HAD NOT BEEN SET UP YET FOR THE PT ON THE TABLE. TECHNICIAN HEARD THE PT SAY "OUCH." WHEN HE LOOKED UP, HE SAW THE TUBE CRANE HAD LOWERED ONTO THE PT'S FOOT. HE RAN OVER TO THE TABLE AND TRIED TO LIFT THE TUBE OFF THE PT'S FOOT, BUT IT WAS STILL DRIVING DOWNWARD. TECHNICIAN WAS ABLE TO REACH ONE OF THE TABLE FOOT SWITCHES TO CANCEL THE COMMAND. AT THAT POINT, THE TUBE STOPPED DRIVING DOWN AND HE WAS ABLE TO LIFT THE TUBE UP OFF OF THE PT'S FOOT. ACCORDING TO TECHNICIANS, THE PT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUINSA DIAGNOSTIC X-RAY SYSTEM IZO SUINSA NOVA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention