BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIOS ALPHA

    MDR report key: 5906839 · Received August 26, 2016

    Report

    Report Number
    2240869-2016-51572
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 15, 2016
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE LOG FILES SHOWED THAT THE FLUOROSCOPY TRIED TO REFRESH THE DISPLAYED IMAGE ON THE SCREEN ACCORDING TO THE SUB/NATIVE MODE BUT IT COULD NOT ACCESS IMAGE CHAIN DUE TO THE ALREADY INITIATED ACQUISITION SEQUENCE. AS A RESULT THE SDLAUSL TELEGRAMS DID NOT GET PROCESSED AND THE MACHINE WAS FROZEN. THIS ISSUE WAS SOLVED BY REWORKING THE HANDLING OF THE TELEGRAM SDIAUSI FOR THE SOFTWARE VERSION VA20. THE ROLL OUT OF THE SOFTWARE IS PERFORMED VIA AN UPDATE INSTRUCTION XP057/15/S (REPORTED UNDER C&R # 2240869-02/26/16-0011-C; Z-1278-2016). THIS REPORT WAS FILED SEPTEMBER 13, 2016.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED TO CONDUCT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT WAS SUBMITTED AUGUST 26, 2016.

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF THE CIOS ALPHA SYSTEM LOCKING UP DURING A CASE WITH A PATIENT ON THE TABLE. THE OPERATOR WAS NOT UNABLE TO SHUT DOWN OR REBOOT THE UNIT. IT TOOK THE OPERATOR 30 MINUTES TO RESET THE UNIT AND RETURN IT TO NORMAL USE. THERE ARE NO INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559181 CIOS ALPHA IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10308191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other