BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2081029 · Received April 14, 2011

    Report

    Report Number
    9617766-2011-00908
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE HARD DISK DRIVE WAS REPLACED. NO FURTHER REPAIR INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STENOSCOP SYSTEM HARD DISK DRIVE NEEDED TO BE REPLACED. 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 (GE PRIVATE) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1