BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARISTOS VX PLUS

    MDR report key: 11628747 · Received April 7, 2021

    Report

    Report Number
    3004754211-2021-72374
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 7, 2021
    Manufacturer
    SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD
    Product Code
    MQB
    PMA / PMN Number
    K013826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS IS SUBMITTING CORRECTION TO SECTION G4 OF THE INITIAL AND FOLLOW-UP MEDWATCH REPORT # 3004754211-2021-72374. A CLERICAL ERROR WAS MADE IN SECTION G4 AND "COMBINATION PRODUCT" WAS CHECKED BY MISTAKE.

    Additional Manufacturer Narrative · 0

    SIEMENS IS FILING A SUPPLEMENT TO THE INITIAL MEDWATCH REPORT # 3004754211-2021-72374 TO CORRECT 510K # PROVIDED IN THE ORIGINAL SUBMISSION. INITIALLY PROVIDED 510K K013826 IS INCORRECT; THE CORRECT 510K IS K983732.

    Additional Manufacturer Narrative · 1

    THE TROLLEY UM PATIENT TABLE FOR THE AXIOM ARISTOS VX PLUS WAS DESIGNED AND VERIFIED ACCORDING TO IEC 60601-1, INCLUDING THE STABILITY TEST IN NORMAL USE, WHICH WAS PASSED SUCCESSFULLY. IN THE OPERATOR MANUAL FOR THE UM PATIENT TABLE IT IS STATED FOR THE OPERATOR TO "MOVE THE TABLE TO AN APPROPRIATE POSITION, LOCK BOTH CASTORS AND ENSURE THE TABLE IS FIXED". IN CASES WHEN PATIENTS ARE LEAVING THE TABLE, THE OPERATOR IS ADVISED TO "LOCK BOTH CASTORS AND HELP THE PATIENT FROM THE TABLE". THE CONCERNED UM PATIENT TABLE WAS INSPECTED BY SIEMENS LOCAL SERVICE. NO DEFECTS OF WHEEL BRAKES WERE FOUND; BOTH CASTORS CAN BE LOCKED BY THE BRAKES ACCORDING TO SPECS. HOWEVER, A FEEDBACK WAS RECEIVED THAT THE OPERATOR WAS NOT SURE WHETHER THE 2 BRAKERS HAD BEEN LOCKED FIRMLY DURING THE OPERATION. IT IS ASSUMED THAT THE REPORTED EVENT OCCURRED DUE TO USER ERROR. INTERNAL ID# (B)(4).

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF AN EVENT THAT OCCURRED ON THEAXIOM ARISTOS VX PLUS UNIT. DURING A SERVICE CALL SIEMENS LOCAL SERVICE ENGIEER WAS INFROMED OF AN INCIDENT WITH A PATIENT. WHEN THE PATIENT WAS GETTING OFF THE TROLLEY UM PATIENT TABLE FOLLOWING LEG EXAMINATION, DUE TO THE TROLLEY UM PATIENT TABLE NOT BEING STABLE, THE PATIENT FELL TO THE GROUND. THIS RESULTED IN PATIENT'S HIP BONE BEING BROKEN. THE INJURY RESULTED IN MEDICAL TREATMENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528162 AXIOM ARISTOS VX PLUS STATIONARY X-RAY SYSTEM MQB SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD 10272410

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other