BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 1981546 · Received January 31, 2011

    Report

    Report Number
    9617766-2011-00190
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    September 2, 2010
    Report Date
    January 31, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVIATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM HANDLE WAS BROKEN. 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) PRIVIATE LTD. STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1