BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3063567 · Received April 12, 2013

    Report

    Report Number
    1720753-2013-04931
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, "IMAGE CREATED ON HARD DRIVE AND IT CANNOT BE RETRIEVED." THE CUSTOMER DESCRIBED A DATA LOSS EVENT. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159213 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1