BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1980151 · Received January 24, 2011

    Report

    Report Number
    9617766-2011-00111
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 24, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE GENERATOR ERROR PROBLEM, BUT REPLACED THE HARD DRIVE FOR THE IMAGE SAVING PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR AND INTERMITTENTLY WOULD NOT SAVE IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. 8800

    Patients

    Seq Age Sex Outcome Treatment
    1