BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5089057 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00012
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    April 6, 2015
    Report Date
    May 28, 2020
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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. 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, 3010157426-2014-00097, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2015 AN ARKON ANESTHESIA MACHINE EXPERIENCED A VENTILATOR FAILED STATE DURING A PATIENT PROCEDURE. THE SYSTEM WAS PLACED INTO MANUAL VENTILATION AND CARE CONTINUED BY THE CLINICIAN. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620666 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown