BEUDAMED
    FDA Adverse Event Death Summary report: N

    OEC ELITE

    MDR report key: 21702698 · Received March 26, 2025

    Report

    Report Number
    1720753-2025-00002
    Event Type
    Death
    Date Received
    March 26, 2025
    Report Date
    June 20, 2025
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OWB
    PMA / PMN Number
    K192819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION AND DETERMINED THAT THE ROOT CAUSE WAS USE ERROR. THE FINDINGS INDICATED THAT THE IMAGING PULSE FRAME RATE (FPS) SETTINGS WERE USED SUB-OPTIMALLY, WITHOUT ANY EVIDENCE OF PRODUCT FAILURE OR MALFUNCTION. THIS USAGE WAS INCONSISTENT WITH THE WARNINGS PROVIDED IN THE USER MANUAL. THE GENERAL DIRECTOR OF THE HOSPITAL STATED AN INTERNAL REVIEW CONCLUDED THAT THE INCIDENT WAS MULTIFACTORIAL DUE TO POOR IMAGE QUALITY AND THE PATIENT'S MEDICAL HISTORY. THE HOSPITAL'S MMR (MORBIDITY AND MORTALITY REVIEW) ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: SURGERY SLC - 384 N WRIGHT BROTHERS DR. USA SALT LAKE CITY, UT 84116.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEATH OF A PATIENT DURING A PROLONGED EVAR PROCEDURE. DURING A SITE VISIT FOLLOWING THIS PROCEDURE THE CLINICIAN EXPRESSED CONCERNS REGARDING THE IMAGE QUALITY DURING THE PROCEDURE WHILE USING THE DIGITAL SUBTRACTED ANGIOGRAPHY MODE. THE CAUSE (INCLUDING ANY CAUSAL RELATIONSHIP BETWEEN THE INCIDENT AND DEVICE) AND CONTRIBUTING FACTORS IN THE PATIENT DEATH HAVE NOT BEEN ESTABLISHED AND INVESTIGATION IS ONGOING RELATED TO THE REPORTED IMAGE QUALITY CONCERNS AND THE PROLONGED EVAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373782 OEC ELITE FLUOROSCOPIC XRAY OWB GE OEC MEDICAL SYSTEMS, INC ELITE FBMHTX00125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death