BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIOS ALPHA

    MDR report key: 12655372 · Received October 19, 2021

    Report

    Report Number
    3004977335-2021-99811
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 19, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    UDI-DI
    04056869009032
    PMA / PMN Number
    K181560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    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, AND SYSTEM HISTORY. PRIOR TO SYSTEM USAGE, THE USER NOTICED LIQUID ON THE DETECTOR AND THEN CALLED SIEMENS SERVICE. IT WAS FOUND THAT COOLING LIQUID WAS LEAKING FROM THE COVER OF THE X-RAY TUBE ONTO THE COVER OF THE DETECTOR. A DETAILED INVESTIGATION REVEALED THAT THE LEAKAGE ORIGINATED FROM THE CONNECTOR BETWEEN THE WATER COOLER AND THE X-RAY TUBE. IT WAS A VERY SLOW LEAK, SO NO BREACH OCCURRED OR WOULD HAVE BEEN EXPECTED TO OCCUR. ACCORDING TO THE INFORMATION GIVEN, THE USER CAME INTO CONTACT WITH THE COOLING LIQUID. AS NO FURTHER INFORMATION IS AVAILABLE AND NO HEALTH CONSEQUENCES HAVE BEEN REPORTED, IT IS ASSUMED THAT THE LIQUID WAS TOUCHED BY THE USER AND THUS HE HAD SKIN CONTACT. SINCE THIS LIQUID (ANTIFROGEN N WATER-MIXTURE 34% FROM CLARIANT) COULD BE ONLY HARMFUL IF SWALLOWED OR COULD BE HARMFUL THROUGH PROLONGED OR REPEATED EXPOSURE, FURTHER THE USER HAD MOST LIKELY WASHED HIS HANDS AFTER CONTACT, HEALTH CONSEQUENCES ARE VERY UNLIKELY OR EVEN IMPOSSIBLE. THE DEFECTIVE CONNECTOR AS WELL AS ALL RELATED CONNECTOR SEALINGS (O-RINGS) HAVE BEEN REPLACED AS PART OF SERVICE ACTIVITY. DUE TO MATERIAL AGING AND WEAKENING, THE OCCURRENCE OF LEAKAGE CANNOT BE COMPLETELY PREVENTED. 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, THEREFORE, 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 WITH THE CIOS ALPHA SYSTEM. THE USER REPORTED A LEAKAGE OF FLUID FROM THE COOOING SYSTEM WHICH COULD POTENTIALLY LEAK INTO THE PATIENT AREA DURING OPERATION. 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
    1556066 CIOS ALPHA INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10308191 04056869009032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown