BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1173203 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26021
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND DETERMINED THE IMAGE PROCESSOR WAS BAD. WAITING ON DECISION FROM CUSTOMER AS TO REPLACEMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUAL. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSOCPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1