BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3162103 · Received June 6, 2013

    Report

    Report Number
    1720753-2013-06821
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND ADJUSTED THE 5 VOLT POWER SUPPLY, AND CLEANED AND RESEATED POWER SUPPLY CONNECTORS. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250469 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1