BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2043505 · Received March 28, 2011

    Report

    Report Number
    9617766-2011-00735
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 28, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM WOULD NOT BOOT UP. 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