BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2021676 · Received February 21, 2011

    Report

    Report Number
    9617766-2011-00396
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GE MED. SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED A WORKSTATION POWER SUPPLY AND REPAIRED A VIDEO CIRCUIT BOARD. MFR'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SMOKE WAS EMITTED FROM THE WORKSTATION DURING A CASE. NO PT OR STAFF INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1