BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1993279 · Received February 7, 2011

    Report

    Report Number
    9617766-2011-00246
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 7, 2011
    Manufacturer
    GE MEDICAL 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

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CABLE ASSEMBLY WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEMS¿ INTERCONNECT CABLE FAILED TO OPERATE PROPERLY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE FLUOROSCOPIC XRAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1