BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2092303 · Received April 27, 2011

    Report

    Report Number
    9617766-2011-00946
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED. NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR OF THE STENOSCOP SYSTEM WOULD NOT TURN ON. 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 (GE PRIVATE) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1