BEUDAMED
    FDA Adverse Event Other Summary report: N

    OEC DIASONICS, INC

    MDR report key: 813215 · Received February 6, 2007

    Report

    Report Number
    MW1041866
    Event Type
    Other
    Date Received
    February 6, 2007
    Date of Event
    January 17, 2007
    Report Date
    January 25, 2007
    Manufacturer
    OEC DIASONICS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD MULTIPLE MALFUNCTION EVENTS; 14 BETWEEN 12/04/06 AND 01/17/07. MACHINE EITHER DOESN'T SHOW IMAGE OR WON'T LET TECH ENTER DATE/TIME. AFTER REBOOTING X 1-2, EQUIPMENT WORKS WITHOUT FURTHER INCIDENTS FOR THAT PARTICULAR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC DIASONICS, INC X-RAY MACHINE (C-ARM) JAA OEC DIASONICS, INC 2580450E1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other