BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5091760 · Received September 21, 2015

    Report

    Report Number
    9611295-2015-00027
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    June 5, 2015
    Report Date
    September 21, 2015
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00131. A SPACELABS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INSPECT THE ANESTHESIA DEVICE. THE FSE PERFORMED VENTILATOR CHECKS AS OUTLINED IN THE SERVICE MANUAL AS WELL AS RAN THE AUTOMATED CHECKOUTS WHICH CHECKS FOR LEAKS. NO TROUBLE WAS FOUND. THE DEVICE PERFORMED TO SPECIFICATIONS. THE DEVICE LOGS DID REGISTER A LEAK AT THE REPORTED EVENT. FSE TESTING WAS PERFORMED WITH A NEW PATIENT CIRCUIT SINCE THE CUSTOMER ELECTED TO DISCARD THE INVOLVED PATIENT CIRCUIT (WHICH MAY HAVE BEEN THE SOURCE OF A LEAK). CONSEQUENTLY, ROOT CAUSE COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INSPECT THE ANESTHESIA DEVICE. THE FSE PERFORMED VENTILATOR CHECKS AS OUTLINED IN THE SERVICE MANUAL AS WELL AS RAN THE AUTOMATED CHECKOUTS WHICH CHECKS FOR LEAKS. NO TROUBLE WAS FOUND. THE DEVICE PERFORMED TO SPECIFICATIONS. THE DEVICE LOGS DID REGISTER A LEAK AT THE REPORTED EVENT. FSE TESTING WAS PERFORMED WITH A NEW PATIENT CIRCUIT SINCE THE CUSTOMER ELECTED TO DISCARD THE INVOLVED PATIENT CIRCUIT (WHICH MAY HAVE BEEN THE SOURCE OF A LEAK). CONSEQUENTLY, ROOT CAUSE COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT IS CONSIDERED FINAL AND THE 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, 3010157426-2014-00131, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1 AND MISTAKENLY IDENTIFIED THE MANUFACTURER BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON JUNE 5, 2015 AN ARKON ANESTHESIA MACHINE DEVELOPED A LEAK WHILE IN USE WHICH CAUSED THE CLINICIAN TO GO TO BAG MODE VENTILATION TO CONTINUE THE CASE. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624140 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1