BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARTIS ZEE FLOOR

    MDR report key: 7269884 · Received February 14, 2018

    Report

    Report Number
    3004977335-2018-00312
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    January 29, 2018
    Report Date
    January 30, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). 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. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE AN ELECTRO STATIC DISCHARGE BETWEEN NURSE, INFUSION STAND AND TABLE. A SERVICE ENGINEER CHECKED THE AFFECTED SYSTEM AND NO LEAKAGE CURRENT COULD BE FOUND. EARTH MEASUREMENTS OF THE TABLE AND THE ACCESSORIES SHOWED NO ABNORMALITIES. THE NURSE REPORTED "A KIND OF LOW LEVEL ELECTRICAL SHOCK". THE MOST PROBABLE CAUSE IS AN ELECTRO STATIC DISCHARGE BETWEEN THE NURSE, THE INFUSION STAND AND THE TABLE. THE REPORTED ELECTRICAL SHOCK IS NOT RELATED TO A MALFUNCTION OF THE ARTIS ZEE SYSTEM. NO CORRECTIVE ACTION IN THE FIELD IS PLANNED BASED ON THE PRESENT EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE AXIOM ARTIS ZEE FLOOR SYSTEM. FOLLOWING A PROCEDURE, A NURSE TURNED OFF THE SYRINGE PUMP AND PULLED THE PLUG OFF THE TABLE. WHILE HOLDING THE PLUG OF THE PUMP IN ONE HAND, SHE TOUCHED THE INFUSION STAND WITH HER OTHER HAND AND RECEIVED AN ELECTRIC SHOCK. IT IS NOT KNOWN AT THIS TIME IF MEDICAL TREATMENT WAS PROVIDED. ADDITIONALLY, WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF ANY PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115103 AXIOM ARTIS ZEE FLOOR SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE GMBH 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other