BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO MAX

    MDR report key: 12703869 · Received October 27, 2021

    Report

    Report Number
    3004977335-2021-02110
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 27, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    UDI-DI
    04056869004273
    PMA / PMN Number
    K181279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT TABLE HAD BEEN LOWERED ONTO THE PATIENT'S LEG RESULTING IN SWELLING OF THE DISTAL THIGH. IT WAS CONFIRMED THAT NO MEDICAL INTERVENTION WAS NECESSARY. THE LOG FILES WERE DELAYED AND NO LONGER CONTAINED THE TIME OF EVENT AS THE LOG FILES WERE OVERWRITTEN. AS THE LOG FILES COVERING THE TIME OF EVENT WERE NO LONGER AVAILABLE FOR INVESTIGATION, THUS, THE SYSTEM CONFIGURATION COULD ALSO NOT BE EXAMINED. THERE IS A WARNING IN THE OPERATOR MANUAL (DOC.ID: XPB7-030.620.01.01.02; REGISTER 2 "SYSTEM SAFETY"; PAGE 38-39) NOT TO POSITION PATIENT LEGS UNDER THE TABLE AND NOT TO MOVE THE TABLE WHILE A PATIENT IS SEATED NEAR THE TABLE. THE PATIENT TABLETOP (NOT THE TABLE FRAME) IS EQUIPPED WITH A COLLISION DETECTION SYSTEM THAT STOPS SYSTEM MOVEMENTS IN CASE A COLLISION IS DETECTED. THE TABLE FRAME ITSELF, PER SYSTEM SPECIFICATIONS, IS NOT EQUIPPED WITH A COLLISION SENSOR. ACCORDING TO THE PROVIDED INFORMATION THE CUSTOMER CONFIRMED THAT THE ISSUE WAS CAUSED BY OPERATOR. NO SYSTEM MALFUNCTION COULD BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE OPERATOR MANUAL CONTAINS A WARNING NOT TO POSITION A PATIENT WITH LEGS UNDER THE TABLE AND NOT TO MOVE THE TABLE WHILE PATIENT IS IN SEATED POSITION NEAR THE TABLE. THE PATIENT TABLETOP IS EQUIPPED WITH A COLLISION DETECTION SYSTEM THAT STOPS SYSTEM MOVEMENT IN CASE A COLLISION IS DETECTED. ONLY THE TABLE FRAME HAS NO COLLISION DETECTION. THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # (B)(6).

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE (B)(6) MAX UNIT. A PATIENT WENT IN FOR EXAMINATION AND WAS SITTING IN A CHAIR NEXT TO THE PATIENT TABLE. WHILE THE TECHNICIAN WAS ADJUSTING THE HEIGHT OF THE PATIENT TABLE, IT MOVED DOWN ONTO THE PATIENTS LEG. THE TECHNICIAN THEN QUICKLY PRESSED THE EMERGENCY BUTTON TO RELEASE THE PATIENT. IT WAS REPORTED THAT PATIENT LEGS WERE PINCHED, AND THIS RESULTED IN THE DISTAL THIGH OF THE PATIENT BEING SWOLLEN. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603652 YSIO MAX STATIONARY X-RAY SYSTEM KPR SIEMENS HEALTHCARE GMBH 10762470 04056869004273

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other