BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1963263 · Received December 31, 2010

    Report

    Report Number
    9617766-2010-00274
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 9, 2008
    Report Date
    December 31, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. RETROSPECTIVE SUMMARY REPORT: (B)(4). TOTAL NUMBER OF EVENTS SUMMARIZED 167. THESE REPORTS ARE BEING FILED LATE DUE TO A RETROSPECTIVE REVIEW OF OUR QUALITY SYSTEM. THESE REPORTABLE MALFUNCTION EVENTS INVOLVE INTERNATIONAL SERVICE DISPATCH RECORDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 8800 SYSTEM HAD MISSING IMAGES. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1