BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 1981480 · Received February 1, 2011

    Report

    Report Number
    9617766-2011-00205
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 1, 2011
    Manufacturer
    GE MED 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 REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A FILTER IN THE MONITOR CART POWER SUPPLY. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM EMITTED AN UNUSUAL ODOR AND WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1