BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5088911 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00011
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    March 25, 2015
    Report Date
    May 27, 2020
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18-SEP-2015: THE CUSTOMER REPORTED THE DEVICE PASSED MORNING CHECKOUT PROCEDURES PRIOR TO USE AND EMERGENCY BACKUP SYSTEMS WORKED AS DESIGNED DURING THE EVENT SO THERE WAS NO INTERRUPTION OF PATIENT CARE. THE MACHINE RETURNED TO NORMAL. SERVICE AFTER A SYSTEM REBOOT. SPACELABS HAS LAUNCHED AN INVESTIGATION OF THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE. ON 12-FEB-2016: BASED ON THE SERVICE LOGS AND ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER, FAULTY COMMUNICATION FROM THE DU TO ACB WAS FOUND. THE ISSUE WAS NOT REPRODUCIBLE; NO TROUBLE WAS FOUND UPON INVESTIGATION; THE UNIT PASSED ALL FUNCTIONAL TESTS. THE UNIT WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. DURING THE EVENT 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, 3010157426-2014-00041, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A MISTAKENLY IDENTIFIED THE MANUFACTURER BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT AN ARKON ANESTHESIA MACHINE SPONTANEOUSLY WENT INTO A FAILED STATE DURING PATIENT USE ON (B)(6) 2015. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620669 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown