BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1880045 · Received October 13, 2010

    Report

    Report Number
    9617766-2010-00625
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    February 26, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE MED. 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

    THE SERVICE CALL WAS CANCELLED BY THE CUSTOMER. THE CUSTOMER INDICATED THE FAULT WAS CLEARED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO MEMORIZE IMAGES. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE FLUOROSCOPY X-RAY JAA GE MED. SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1