BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2093127 · Received May 3, 2011

    Report

    Report Number
    9617766-2011-00989
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 3, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WHEN RETRIEVING SAVED IMAGES, THEY DID NOT MATCH UP WITH THE PATIENT INFORMATION. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1