BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE INNOVA 2000

    MDR report key: 416316 · Received September 10, 2002

    Report

    Report Number
    MW1026135
    Event Type
    Malfunction
    Date Received
    September 10, 2002
    Date of Event
    August 21, 2002
    Report Date
    August 21, 2002
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRIPPED OVER GUARD ON X-RAY FOOT PEDAL. FELL TO FLOOR ON HANDS AND KNEES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/28/02: IT WAS REPORTED TO GE THAT A NURSE BROKE THEIR RIGHT FOOT BY STEPPING INTO THE FOOTSWITCH ASSEMBLY, SUBSEQUENTLY TRIPPING AND FALLING. THIS OCCURRED WHILE SETTING UP FOR A CASE WITH A PT ON THE TABLE. FURTHER INVESTIGATION SHOWED THAT THE NURSE TRIPPED ON THE FOOTSWITCH PROTECTION ARC. THIS ARC IS INTENDED TO PROVIDE AGAINST UNINTENDED INITIATION OF EXPOSURE AND SUCH PROTECTION IS REQUIRED BY THE IEC 601-2-7 STANDARD. THERE IS NO FIELD HISTORY FOR THIS TYPE OF INCIDENT WITH THIS DESIGN. IT IS CONSIDERED STATE OF THE ART TO USE A FOOTSWITCH AT THE TABLE TO INITIATE X-RAY AND IS PART OF THE CONFIGURATION FOR THIS DEVICE. CONSIDERING THAT THE FOOTSWITCH IS ON THE FLOOR, IT CAN BE A TRIPPING HAZARD, BUT USERS OF THIS SYSTEM SHOULD BE AWARE THAT THEY HAVE CHOSEN A SYSTEM WITH A FOOTSWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE INNOVA 2000 X-RAY FOOT PEDAL IZO G.E. MEDICAL SYSTEMS INNOVA 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other