BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2102734 · Received May 23, 2011

    Report

    Report Number
    1720753-2011-07532
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT MONITOR NEEDS TO BE REPAIRED. THE CUSTOMER ELECTED TO USE A THIRD PARTY FOR THE REPAIR. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S LEFT MONITOR WOULD NOT WORK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1