BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5207629 · Received November 6, 2015

    Report

    Report Number
    9611295-2015-00031
    Event Type
    Malfunction
    Date Received
    November 6, 2015
    Date of Event
    October 21, 2015
    Report Date
    September 25, 2017
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SERVICE LOGS AND ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER, FAULTY COMMUNICATION FROM THE DU TO ACB WAS FOUND. DU PN 050-9003-00 WAS REPLACED AND THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS. THE REPAIRED UNIT WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. DURING THE DU COMMUNICATION ISSUE CLINICAL STAFF RESPONDED APPROPRIATELY PER THEIR TRAINING; MANUAL VENTILATION, MEDICAL GASES AND ALARMS REMAINED OPERATIONAL. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THIS PARTICULAR ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER MEDICAL DEVICE EVALUATION RESULTS CODE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT THE ARKON ANESTHESIA MACHINE WENT INTO A FAILED STATE WHILE IN USE ON (B)(6) 2015. THE DEVICE BEGAN TO FUNCTION NORMALLY AFTER RESET. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738496 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1