BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1241676 · Received November 19, 2008

    Report

    Report Number
    9680959-2008-00217
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP HAD THE TECH CHECK THE FOOT PEDAL AND SHE FOUND THE CORD WOUND TIGHTLY AROUND THE PEDAL. SHE REMOVED THE FOOT PEDAL FROM THE HOLDER AND UNWOUND CORD. THE SYSTEM BOOTS AND FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DOES NOT BOOT PROPERLY, THE TEMP ALARM CONTINUES TO BLINK AND THE SYSTEM WILL NOT TAKE X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1