BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q.ZEEGO

    MDR report key: 12377035 · Received August 27, 2021

    Report

    Report Number
    3004977335-2021-93587
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 27, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    UDI-DI
    04056869010007
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IN A ROBOTIC SYSTEM, TWO ROOM LIMITATIONS FOR THE RANGE OF MOTION ARE ACTIVE. THE FIRST BEING THE "STAND CONTROL UNITS" (SCU) SET LIMITS (ROOM LIMITS). WHEN REACHING THOSE, THE USER IS INFORMED BUT STILL ABLE TO DRIVE THE SYSTEM AWAY FROM THE BORDERS OF THE ALLOWED MOVEMENT AREA. THE SECOND SET OF LIMITS ARE THE ROBOTIC INTERNALLY SET LIMITS (SAFERDW LIMITS) WHICH ARE SLIGHTLY HIGHER THAN THE SCU ROOM LIMITS. IN REGULAR OPERATION, THE USER IS UNABLE TO DRIVE INTO THE SAFERDW LIMITS. IN THE EVENT THE ROBOT IS DRIVEN BEYOND THE SAFERDW LIMITS (E.G., PROVOKED BY A SYSTEM ISSUE OR AN ISSUE WITH THE ROOM LIMITS) FURTHER MOVEMENT IS BLOCKED FOR SAFETY REASONS. IF LIMITS ARE BREACHED, IT IS ONLY POSSIBLE TO DRIVE THE ROBOT OUT OF THE "SAFERDW LIMITS" AS PART OF REACTIVE SERVICE ACTIVITY. IT COULD BE DETERMINED THAT THE ZEEGO SYSTEM HAD AN ISSUE WITH THE ROOM LIMITS. THE USER RECEIVED THE ERROR MESSAGE "STAND/TABLE ERROR, CALL SC" BUT WAS STILL ABLE TO MOVE THE SYSTEM. IN THIS ERRONEOUS SCENARIO, THE CUSTOMER WAS ADVISED TO RESET THE SCU. UNFORTUNATELY, THE SCU WAS NOT RESET, AND THE ROBOT COULD AND WAS DRIVEN INTO THE "SAFERDW LIMITS". AS A RESULT, FURTHER ROBOT MOVEMENT WAS BLOCKED, AND SYSTEM OPERATION COULD ONLY BE RESTORED AS PART OF SERVICE ACTIVITY. AFTER THE REACTIVE SERVICE INTERVENTION, THE ERROR DID NOT OCCUR AGAIN. AFTER DETAILED INVESTIGATION, THE INCIDENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AS NEITHER SERIOUS INJURY, DEATH NOR AN UNEXPECTED, PROLONGED HOSPITALIZATION OF THE PATIENT OR ANY OTHER PERSON OCCURRED OR COULD BE EXPECTED.

    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 Q.ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT C-ARM MOVEMENT WAS NOT POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. DURING TRANSFER TO AN ALTERNATE TABLE, THE SHEATH IN THE PATIENT WAS PULLED OUT. PRESSURE WAS APPLIED TO STOP BLEEDING. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT 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
    1273980 ARTIS Q.ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10848283 04056869010007

    Patients

    Seq Age Sex Outcome Treatment
    1