BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2022234 · Received February 28, 2011

    Report

    Report Number
    9617766-2011-00474
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 28, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PREFORMED AN ON SITE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM LOCK-UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1