BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOBILE C-ARM SERIES 6600

    MDR report key: 403602 · Received July 1, 2002

    Report

    Report Number
    1720753-2002-00004
    Event Type
    Other
    Date Received
    July 1, 2002
    Date of Event
    June 7, 2002
    Report Date
    June 28, 2002
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OPERATOR OF A C-ARM SYSTEM COULD NOT TERMINATE FLUORO AFTER RELEASING THE FOOTSWITCH PEDAL. THE FOOTSWITCH EXPOSURE PEDAL COVER WAS BENT PREVENTING THE PEDAL FROM RELEASING. THE FIELD SERVICE ENGINEER REPAIRED THE FOOTSWITCH PEDAL COVER. THE FIELD SERVICE ENGINEER REMOVED AND STRAIGHTENED THE EXPOSURE COVER ON THE FOOTSWITH PEDAL. AFTER THE FOOTSWITCH WAS MADE OPERATIONAL THE C-ARM SYSTEM WAS RETURNED TO SERVICE. THE HOSPITAL REPORTED THAT THERE WASN'T ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE C-ARM SERIES 6600 MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM IZL GE OEC MEDICAL SYSTEMS, INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other