BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2152904 · Received June 17, 2011

    Report

    Report Number
    1720753-2011-08281
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SVC REP CONDUCTED AN ONSITE INVESTIGATION. THE INTELLIGENT SHUTDOWN BOARD AND THE ON/OFF SWITCH WERE REPLACED. THE CUSTOMER REPLACED THE INTERCONNECT CABLE AND THE UNINTERRUPTED POWER SUPPLY BOARD BATTERY. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1