BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEUS XR/A

    MDR report key: 1629995 · Received March 11, 2010

    Report

    Report Number
    9613445-2010-00001
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 24, 2010
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO IN THE REPORT, THERE WAS NO MALFUNCTION OF THE X-RAY SYSTEM THAT CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY. NO FURTHER ACTION WAS REQUIRED.

    Description of Event or Problem · 1

    A HOSPITAL TECHNICIAN REPORTED AN INCIDENT TO A GE FIELD ENGINEER AT THE CUSTOMER SITE INVOLVING AN INJURY SUSTAINED BY A PT AT THE END OF AN X-RAY EXAM. DURING THIS TIME, THE PT WAS SITUATED ON THE TABLE AND CONNECTED TO AN INTRAVENOUS (IV) POLE, WHOSE BASE WAS LOCATED IN CLOSE PROXIMITY TO THE TABLE BASE. AS THE TECHNICIAN LOWERED THE CABLE, THE CABLE'S TELESCOPIC FRONT COVER CONTACTED THE IV POLE'S BASE, CAUSING THE POLE TO TIP AND CONTACT THE PT'S HEAD. THE PT RECEIVED A CUT ABOVE HER EYE. THE INJURY REQUIRED TREATMENT, INCLUDING SUTURES. THE TECHNICIAN INDICATED THAT THERE WAS NO MALFUNCTION OF THE X-RAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEUS XR/A KPR GE HANGWEI MEDICAL SYSTEMS CO., LTD. 2259988

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R IV POLE