BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL CAPNOGRAPHY MODULE

    MDR report key: 2575565 · Received May 15, 2012

    Report

    Report Number
    3023361-2012-00022
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    April 17, 2012
    Report Date
    July 16, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    MHX
    PMA / PMN Number
    K031124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE WAVEFORMS AND NUMBERS DISAPPEARED AFTER 30 MINUTES. THE INVESTIGATION IS UNDERWAY. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER EVALUATED THE SUBJECT DEVICE AT THE CUSTOMER'S SITE. THE ROOT CAUSE WAS IDENTIFIED AS AN UNCOMMON WORKFLOW IN WHICH A HUMIDIFIER WAS USED IN THE PATIENT BREATHING CIRCUIT AND CAUSED AN OCCLUSION IN THE SAMPLING LINE. AN EXCESSIVE AMOUNT OF WATER COLLECTED IN THE GAS SAMPLING LINE AND BLOCKED THE GAS FLOW. AS A RESULT, THE READING WENT TO ZERO AND WAVEFORM DEGRADED. THE DEVICE GAVE AN OCCLUSION ALARM TO ALERT THE USER TO PREVENT INJURY. THE CUSTOMER HAS BEEN MADE AWARE OF THIS. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A MODEL 91517 CAPNOGRAPHY MODULE STOPPED WORKING AFTER 30 MINUTES.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A MODEL 91517 CAPNOGRAPHY MODULE STOPPED WORKING AFTER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW SL CAPNOGRAPHY MODULE ULTRAVIEW CAPNOGRAPHY MODULE MHX SPACELABS MEDICAL INC. 91517

    Patients

    Seq Age Sex Outcome Treatment
    1