BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 8463673 · Received March 29, 2019

    Report

    Report Number
    3004977335-2019-73894
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K123529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. THE CONSTRUCTION OF THE UPPER BODY RADIATION PROTECTION (PORTEGRA2) ARM IS DESIGNED WITH LEAD GLASS WHICH IS CONNECTED TO THE ARM HOLDER BY A BALL JOINT. THE BALL IS HELD BY A POLYETHYLENE PART INSIDE A METAL FLANGE. THE RADIATION PROTECTION IS USED TO PROTECT THE UPPER AND LOWER BODY PARTS OF THE OPERATOR AND CAN BE PARTIALLY PLACED ABOVE THE TABLE. THE AFFECTED UPPER BODY RADIATION PROTECTION ARM WAS REPLACED BY A SIEMENS SERVICE ENGINEER AND THE RETURNED PART WAS EXAMINED BY THE MANUFACTURER. THE INVESTIGATION IDENTIFIED A PRESSED OUT BALL OF THE BALL JOINT BY INCREASED FORCE ON THE LEAD GLASS FROM BELOW. IF THE LEAD GLASS IS TILTED WITH INCREASED FORCE UNTIL THE END LIMITS OF MOVEMENT, THE BALL CAN BE PRESSED OUT OF THE FLANGE. IN THIS CASE, THE PIVOT POINT WAS COMPLETELY SEIZED UP AND COULD NOT BE ROTATED AT ALL. AS A RESULT, THIS CONTRIBUTED TO THE SHIELD FAILING AT THE BALL JOINT. IN THE "INSTRUCTIONS FOR USE - PORTEGRA2", CHAPTER 3.5, IT IS WRITTEN, THAT THE SYSTEM SHOULD ONLY BE MOVED BY THE DEFINED POINTS / HANDLES. SYSTEM OPERATOR MANUAL: THE OPERATOR MANUAL CONTAINS DETAILED INFORMATION ON UNIT MOVEMENTS. CHAPTER "SYSTEM OPERATION" - SUBCHAPTER "INITIATING UNIT MOVEMENTS": CAUTION: RISK OF COLLISION, RISK OF INJURY TO PATIENT OR OPERATOR, RISK OF DAMAGE TO UNIT PARTS. IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT UNIT MOVEMENTS ARE RELEASED ONLY IF IT IS CERTAIN THAT NEITHER THE OPERATOR, THE PATIENT, THIRD PARTIES NOR OTHER PIECES OF EQUIPMENT CAN BE ENDANGERED BY THESE MOVEMENTS. ALWAYS PAY ATTENTION TO POSSIBLE COLLISIONS DURING UNIT MOVEMENTS. MAKE SURE THAT NOBODY IS STANDING INSIDE THE DANGER AREA. REMOVE ANY OBJECTS OR ACCESSORIES FROM COLLISION AREA, E.G. INJECTOR OR INFUSION STAND. THE UPPER BODY RADIATION PROTECTION HAS BEEN EXCHANGED BY THE LOCAL SERVICE ORGANIZATION AND THE ERROR DID NOT REOCCUR. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. THE OCCURRENCE RATE IS BELOW THE DEFINED THRESHOLD. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. THE USER REPORTED THAT THE LEAD SHIELD FELL OFF OF THE SUPPORT ARM. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257629 ARTIS ZEE FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1