BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 6030405 · Received October 14, 2016

    Report

    Report Number
    9611295-2016-00004
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2016
    Report Date
    May 3, 2018
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TAKEN OFF OF THE DEVICE AND BAGGED USING AN AMBU BAG. THE DEVICE WAS RESTARTED, THE PATIENT RECONNECTED AND THE CASE FINISHED. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A SPACELABS'' FIELD SERVICE ENGINEER PERFORMED AN INVESTIGATION OF THE SERVICE LOGS AND CONFIRMED THE REPORTED COMPLAINT. INVESTIGATIVE FINDINGS INDICATE THE ARKON ENTERED INTO A DU RESET/FAILED STATE. THIS ISSUE HAS BEEN RESOLVED IN FDA RECALL NUMBER Z-0072-2018 AND ALL ITEMS ADDRESSED. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2016 THAT THE DEVICE WENT INTO FAILED STATE DURING A CASE. THERE WAS NO REPORT OF PATIENT INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680923 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1