BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1910036 · Received November 10, 2010

    Report

    Report Number
    9617766-2010-00728
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 10, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIAN) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM LOCKED UP, THEN RESTARTED DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1