BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUS XR/A

    MDR report key: 1361328 · Received January 13, 2009

    Report

    Report Number
    9613445-2009-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 18, 2008
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND WAS ABLE TO REPRODUCE THE REPORTED FLOAT. THE FE ALSO FOUND THAT THE LOCKS WOULD ALSO INTERMITTENTLY ENGAGE AFTER A FEW MINS WITH NO ACTION FROM THE OPERATOR. FURTHER INVESTIGATION BY THE FE REVEALED THAT THE OPTO-COUPLER OR THE TRANSISTOR IN THE PRINTED CIRCUIT BOARD (PCB) WAS LEAKING, LEADING TO THE MALFUNCTION. THE FE REPLACED THE PCB AND VERIFIED THAT THE LOCKS WERE OPERATING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE TECHNOLOGIST RELEASED THE FOOT PEDAL, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVED IN BOTH LATERAL AND LONGITUDINAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SET-UP WHILE THE INHIBIT SWITCH WAS ACTIVATED AND THE FOOT PEDAL WAS NO LONGER DEPRESSED. ACCORDING TO THE TECHNOLOGIST, THE ISSUE WAS INTERMITTENT BECAUSE LOCKS WOULD EVENTUALLY ENGAGE AFTER ACTIVATING THE INHIBIT SWITCH MULTIPLE TIMES. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL

    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