BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1820056 · Received August 23, 2010

    Report

    Report Number
    1720753-2010-02725
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CANCELLED CALL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN TAKING IMAGES, THEY HAVE LINES AND GRAINY IMAGES. THE AUTOMATIC EXPOSURE CONTROL IS NOT WORKING. SYSTEM DID NOT BOOT IN AUTO ABS MODE INTERMITTENTLY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUORORSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1