BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2152244 · Received June 23, 2011

    Report

    Report Number
    1720753-2011-08433
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 23, 2011
    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

    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 WOULD LOCK UP DURING EXPOSURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1