BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5159708 · Received October 19, 2015

    Report

    Report Number
    9611295-2015-00030
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Date of Event
    October 7, 2015
    Report Date
    June 16, 2016
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ONSITE INVESTIGATION OF THE ARKON ANESTHESIA SYSTEM BY SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE BAG TO VENT (BTV) SWITCH FAILED. THE FIELD SERVICE ENGINEER REPLACED THE BAG TO VENT SWITCH AND VERIFIED THAT THE ANESTHESIA SYSTEM PASSED ALL TESTS. THE SYSTEM LOGS NOTED THE PREMATURE FAILURE OF THE SWITCH AT APPROXIMATELY 1700 CYCLES. THE FAILED BTV SWITCH PART WAS SENT TO EXTERNAL CONSULTANT WHO REPORTED THAT THE PART FAILURE APPEARED THE RESULT OF A CHEMICAL AGENT IN COMBINATION WITH NORMAL STRESSES RESULTED IN ENVIRONMENTAL STRESS CRACKS. A REVIEW OF SPACELABS¿ MANUFACTURING PROCESS, SUPPLIER PROCESSES AND THE CUSTOMER¿S PROCESSES FAILED TO IDENTIFY ANY CHEMICAL AGENT THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THERE ARE NO SIMILAR FAILURES NOTED FOR THIS PART, SPACELABS CONCLUSION IS THAT THIS IS AN ISOLATED COMPONENT FAILURE. THIS INVESTIGATION IS CONSIDERED COMPLETED AND THIS PARTICULAR ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2015 THE ARKON ANESTHESIA MACHINE'S BAG TO VENT SWITCH FAILED DURING PATIENT USE. NO ONE WAS INJURED AS A RESULT OF THIS EVENT. THE PATIENT CASE WAS COMPLETED VIA MANUAL BAGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689582 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR