BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2021817 · Received February 25, 2011

    Report

    Report Number
    9617766-2011-00470
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 26, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM BEAM WAS NOT PROPERLY COLLIMATED. NO PATIENT 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