BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 4974332 · Received August 5, 2015

    Report

    Report Number
    9611295-2015-00001
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 10, 2015
    Report Date
    October 13, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE TESTING OF THE INVOLVED DEVICE PERFORMED BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE TESTING WAS WITNESSED BY A FACILITY STAFF MEMBER. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A COMPLETE REPORT WHEN THE INVESTIGATION IS FINISHED.

    Additional Manufacturer Narrative · 1

    ONSITE INVESTIGATION OF THE INVOLVED DEVICE BY A SPACELABS FIELD SERVICE ENGINEER DETERMINED THERE WAS NO MALFUNCTION. NO TROUBLE WAS FOUND WITH THE DEVICE WHEN THE SAME CIRCUIT IS USED FOR BOTH THE CHECKOUT PROCEDURE AND PATIENT. THE EQUIPMENT LOGS INDICATE AN ADULT PATIENT CIRCUIT WAS USED BY THE CUSTOMER TO RUN THE AUTOMATED CHECKOUT PROCEDURE WHICH MEASURES SYSTEM COMPLIANCE. THE CUSTOMER STATED THEY DID NOT RERUN THIS PROCEDURE WITH A PEDIATRIC CIRCUIT (AS RECOMMENDED IN THE OPERATIONS MANUAL) WHEN THEY SELECTED A PEDIATRIC CIRCUIT FOR PATIENT USE. THIS REPORT IS CONSIDERED FINAL AND THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT AN ARKON ANESTHESIA MACHINE STOPPED VENTILATING IN THE MIDDLE OF A CASE ON (B)(6) 2015 AT 7:30 A.M. NO ERROR INDICATORS DISPLAYED. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517173 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1