BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2062908 · Received March 21, 2011

    Report

    Report Number
    9617766-2011-00644
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 21, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 8800 SYSTEM WOULD LOCK UP. NO REPORTS OF PATIENT INJURY RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1