BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 1973554 · Received January 19, 2011

    Report

    Report Number
    9617766-2011-00092
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 24, 2010
    Report Date
    January 19, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. GE REP APPLIED CONTACT RE-ENFORCER TO THE CONNECTORS OF CIRCUIT BOARDS AND CABLES, AND REPLACED THE SINGLE BOARD COMPUTER'S CMOS MEMORY BATTERY AS A PREVENTATIVE MEASURE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATION FAILURE AND WOULD NOT FLUORO. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1