BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2062129 · Received April 6, 2011

    Report

    Report Number
    9617766-2011-00809
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE IMAGE OSCILLATION WAS CORRECTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE DISAPPEARED ON THE STENOSCOP SYSTEM WHEN THE SCOPE PEDAL WAS PRESSED. 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