BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 10747160 · Received October 28, 2020

    Report

    Report Number
    3004977335-2020-52284
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 28, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    UDI-DI
    04056869010045
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 HARDWARE ERROR. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY, SYSTEM LOG FILES AND AFFECTED PART(S). UPON INVESTIGATION, THE INVOLVED CUSTOMER SERVICE ENGINEER (CSE) IDENTIFIED AN ISSUE WITH ONE PRINTED WIRING BOARDS (PWB) (D510). THE CSE RETURNED THE PART TO THE MANUFACTURER FOR DETAILED INVESTIGATION. THE RETURNED PART WAS EXAMINED IN DETAIL AND SHOWED THAT THE ISSUE WAS A DEFECTIVE TRANSFORMER (T4). AS A RESULT, NO X-RAY WAS AVAILABLE. THE PWB WAS EXCHANGED BY THE LOCAL SERVICE ORGANIZATION AND THE SYSTEM WORKS AS SPECIFIED. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. AS OCCURRENCE RATE IS BELOW THE DEFINED THRESHOLD, NO CORRECTIVE ACTION IS NECESSARY. 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 ZEE FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. 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
    1211191 ARTIS ZEE FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10094135 04056869010045

    Patients

    Seq Age Sex Outcome Treatment
    1