BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEUS

    MDR report key: 24831350 · Received April 9, 2026

    Report

    Report Number
    9613445-2026-00003
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 15, 2026
    Report Date
    May 28, 2026
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: GE HANGWEI MEDICAL SYSTEMS CO., LTD. WEST AREA OF BUILDING NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT AREA, BEIJING, CHINA 100176. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A USER AT (B)(6) (USA) REPORTED AN INCIDENT THAT OCCURRED ON (B)(6) 2026 INVOLVING THE OVERHEAD TUBE SUSPENSION (OTS) OF THEIR PROTEUS FIXED RADIOGRAPHIC IMAGING SYSTEM. ACCORDING TO THE REPORT, DURING ROUTINE CLEANING OF THE TABLETOP, THE TECHNOLOGIST LIFTED THEIR HEAD AND CONTACTED THE UNDERSIDE OF THE OTS GOOSENECK ASSEMBLY. THE CONTACT REPORTEDLY RESULTED IN A LACERATION TO THE TOP OF THE TECHNOLOGIST¿S HEAD. THE TECHNOLOGIST RECEIVED MEDICAL TREATMENT CONSISTING OF TWO STAPLES AND ONE SUTURE. BASED ON THE INFORMATION PROVIDED, THE DEVICE WAS STATIONARY AND OPERATING AS INTENDED AT THE TIME OF THE EVENT. NO DEVICE MALFUNCTION, UNEXPECTED MOVEMENT, OR MECHANICAL FAILURE OF THE OTS ASSEMBLY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69984 PROTEUS SYSTEM, X-RAY, STATIONARY KPR GE HANGWEI MEDICAL SYSTEMS CO., LTD. XRA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention