BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800MD

    MDR report key: 955908 · Received November 30, 2007

    Report

    Report Number
    1720753-2007-08088
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 30, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP VERIFIED NORMAL/HLF DOSE USING 9800 SERVICE MANUAL SPECS. SYSTEM IS IN SPEC. FOUND NORMAL LEVEL 8.9R/MIN/HLF AT 17.1R/MIN. THIS COMPLIES WITH NYS AND FEDERAL REQUIREMENTS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PHYSICIST DISCREPANCY. NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR