BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIOS ALPHA

    MDR report key: 4919610 · Received July 14, 2015

    Report

    Report Number
    2240869-2015-03320
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    SIEMENS GMBH
    Product Code
    OWB
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED (B)(6)2015. CUSTOMER'S ADDRESS: (B)(6) HOSPITAL, (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THAT ACTIVATION OF THE TECH-LOCK BUTTON RESULTS IN IMAGE CHAIN PARAMETERS FREEZE. ACTIVATION OF THE TECH-LOCK BUTTON PRIOR TO FIRST RADIATION RELEASE LEADS TO PARAMETERS FREEZE WHICH MAY RESULT IN BAD QUALITY IMAGES. THE CUSTOMER WAS INFORMED ABOUT THIS SYSTEM BEHAVIOR. THIS INFORMATION WAS INCLUDED IN THE USER MANUAL AND DISTRIBUTED VIA AN UPDATE INSTRUCTION XP018/15/S (C&R # 2240869-05/08/2015-0014-C; Z-01958-2015). ADDITIONALLY SIEMENS IS PLANNING ON ILLUMINATING THE TECH-LOCK BUTTON IF KV/MA STOP IS ACTIVATED FOR BETTER VISIBILITY. THIS OPTION WILL BE INTRODUCED ON SYSTEMS RUNNING ON VA20 SOFTWARE VERSION. THE VA20 SOFTWARE VERSION WAS RELEASED VIA AN UPDATE INSTRUCTIONS XP053/15/S AND XP057/15/S (C&R # 2240869-02/26/16-0011-C). THIS REPORT WAS SUBMITTED MARCH 11, 2016.

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF THE CIOS ALPHA SYSTEM GETTING LOCKED DURING A MEDICAL INTERVENTION WITH A PT BEING PRESENT ON THE TABLE. THE SYSTEM COULD NOT BE USED FOR APPROXIMATELY 10-20 MINUTES. THE ISSUE OCCURRED DUE TO THE OPERATOR INCORRECTLY ACTIVATING A FUNCTION THAT REGULATES RADIATION PARAMETERS. THIS RESULTED IN POOR QUALITY IMAGES. THE OPERATOR MADE A DECISION TO PROCEED ON A DIFFERENT SYSTEM. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THIS ISSUE WAS REPORTED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455461 CIOS ALPHA IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY OWB SIEMENS GMBH 10308191 NA

    Patients

    Seq Age Sex Outcome Treatment
    1