BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1900409 · Received October 26, 2010

    Report

    Report Number
    9617766-2010-00673
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    May 12, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. A QUOTE FOR A NEW HARD DRIVE WAS GIVEN TO THE FACILITY. WAITING ON APPROVAL FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CINE DRIVE FAILED TO SAVE RUNS. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1