BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ARKON ANESTHESIA WORKSTATION

    MDR report key: 5088691 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00007
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    January 24, 2015
    Report Date
    September 18, 2015
    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

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00019. THE INVOLVED DEVICE WAS REPAIRED BY A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS). THE PSS CONFIRMED THAT THE PLASTIC FILM OVER THE HEAT TRANSFER PAD HAD NOT BEEN REMOVED RESULTING IN THE FAILED STATE DISPLAY. THE DEVICE WAS REPAIRED UNDER WARRANTY, TESTED PER SPACELABS ARKON TECHNICAL MANUAL AND RETURNED TO SERVICE HAVING PASSED ALL TESTS. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620660 SPACELABS ARKON ANESTHESIA WORKSTATION ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR CBK SPACELABS HEALTHCARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1