BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC ELITE

    MDR report key: 16880116 · Received May 5, 2023

    Report

    Report Number
    1720753-2023-00002
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 4, 2023
    Report Date
    June 23, 2023
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OBW
    PMA / PMN Number
    K170752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE CAUSE WAS DETERMINED TO BE A GEHC SPECIFICATION NOT BEING MET BY A SUPPLIER OF THE IMAGE INTENSIFIER. AS A RESULT OF THE INVESTIGATION A CORRECTION WAS INITIATED BY GEHC (RECALL NO. FMI 15146) AND FILED TO FDA. THE DEVICE HAD NOT YET BEEN INSTALLED OR PLACED IN USE AS THE ISSUE OCCURRED DURING TRANSIT AND THEREFORE THERE WAS NO PATIENT OR USER INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS INVESTIGATION IS ONGOING. THIS MDR IS BEING FILED IN AN ABUNDANCY OF CAUTION AT THIS TIME. BLOCK D4 UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: SURGERY SLC - 384 N WRIGHT BROTHERS DR USA SALT LAKE CITY, UT 84116.

    Description of Event or Problem · 0

    ON APRIL 4, 2023, IT WAS DISCOVERED INTERNALLY THAT THE SYSTEM HAD A SEPARATED IMAGE INTENSIFIER. THERE WAS NO INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691770 OEC ELITE FLUOROSCOPIC XRAY OBW GE OEC MEDICAL SYSTEMS, INC N/A FSXXTX00421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown