BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS QUBE COMPACT MONITOR

    MDR report key: 4996423 · Received August 12, 2015

    Report

    Report Number
    3010157426-2015-00158
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 15, 2015
    Report Date
    October 16, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K120616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION OF THIS ISSUE AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS DECIDED THAT THEY WILL NO LONGER USE THE QUBE COMPACT MONITOR MODEL 91390 (SERIAL NUMBER: (B)(4)) FOR PATIENT TRANSFER DUE TO BREAKAGE OF THE CAPNOPOD MODEL 92516 CONNECTION. THE CUSTOMER STATED THERE WAS A DISCONNECTION OF THE CAPNOPOD TERMINALS DURING TRANSFER RESULTING IN LOSS OF CAPNOGRAPHY ON INTUBATED PATIENTS. ADDITIONALLY, THE NOMOLINE CLIP BROKE (THIS CONNECTION SITS AT A RIGHT ANGLE TO THE MONITOR SCREEN). THE QUBE WAS REPLACED WITH A UVSL MONITOR AND TWO BAY HOUSING FOR THE CAPNOPOD INTEGRATION AS THE CUSTOMER REQUESTED. HOWEVER, THE CUSTOMER REPORTED PROBLEM COULD NOT BE VERIFIED BY A SPACELABS PRODUCT SUPPORT SPECIALIST PERFORMING THE INVESTIGATION IN SNOQUALMIE, WASHINGTON. BASED ON THE CUSTOMER PROVIDED INFORMATION, ROOT CAUSE COULD NOT BE DETERMINED. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2015 THAT THE QUBE COMPACT MONITOR MODEL 91390 WITH CAPNOPOD INTERFACE ((B)(4)) DISCONNECTS LOSING VITAL CAPNOGRAPHY VALUES ON INTUBATED PATIENTS DURING TRANSPORT. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529736 SPACELABS QUBE COMPACT MONITOR QUBE COMPACT MONITOR MHX SPACELABS HEALTHCARE INC. 91390

    Patients

    Seq Age Sex Outcome Treatment
    1