BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5089833 · Received September 19, 2015

    Report

    Report Number
    9611295-2015-00021
    Event Type
    Malfunction
    Date Received
    September 19, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 2, 2020
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE INVESTIGATION OF THE ARKON ANESTHESIA SYSTEM BY SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATION,S AND THE PRESSURE SUPPORT VENTILATION-CONTINUOUS POSITIVE AIRWAY PRESSURE (PSV-CPAP) MODE WAS SELECTED DURING THE REPORTED EVENT. THE USER¿S MANUAL STATES THAT THE PSV-CPAP MODE IS A MODE OF VENTILATION USED WHEN THE PATIENT IS SPONTANEOUSLY BREATHING ON THEIR OWN WHICH WAS INAPPROPRIATE FOR THIS PATIENT. THIS INVESTIGATION IS CONSIDERED COMPLETE, AND THIS PARTICULAR ISSUE CLOSED. THIS REPORT IS BEING GENERATED AT THE DIRECTION OF FDA BECAUSE OF SUPPLEMENTAL REPORTS RECEIVED, WITH THIS MANUFACTURER REPORT NUMBER, AND NO RECORD OF AN INITIAL REPORT.  THIS MANUFACTURER REPORT IS SUBMITTED TO CORRECT A PREVIOUS REPORT, 3010157426-2014-00117, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1, AND SECTION G(9) AND MISTAKENLY IDENTIFIED THE MANUFACTURER IN SECTION D(3) BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT DURING A CASE ON MAY 20, 2015, AN ARKON ANESTHESIA MACHINE BEGAN HISSING FROM THE REAR OF THE MACHINE, AND THERE WAS NO VENTILATION. NO ONE WAS INJURED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621224 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown