BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS QUBE COMPACT MONITOR

    MDR report key: 3958890 · Received July 28, 2014

    Report

    Report Number
    3010157426-2014-00009
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    January 20, 2014
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K120616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS FIELD SERVICE ENGINEER (FSE) WILL BE ON-SITE FOR TESTING TODAY. WE WILL FOLLOW UP WITH THE FSE FOR MORE INFORMATION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SPO2 ALARM LIMITS WERE OFF EACH TIME WHEN A NEW PATIENT WAS ADMITTED EVEN THOUGH THE SPO2 ALARM LIMITS DEFAULT SETTINGS WAS TURNED ON IN THE PRODUCT MODULE CONFIGURATION MANAGER (MCM). THE NURSE HAD TO MANUALLY TURN ON THE ALARM LIMITS. SPACELABS SENT A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE DEVICE ONSITE AND OBTAIN ADDITIONAL INFORMATION FROM THE CLINICAL STAFF. FUNCTIONAL TESTS WERE PERFORMED ON THE MONITOR AND MODULE IN ACCORDANCE WITH THE SERVICE MANUAL. ALL TESTS PASSED. OUR INVESTIGATION FOUND THAT THE PRODUCT PERFORMED AS DESIGNED. WHEN A NEW PATIENT WAS ADMITTED ONTO THE MONITOR AND THE SPO2 CABLE WAS CONNECTED TO THE MODULE, BUT BEFORE THE SPO2 CABLE/SENSOR WAS CONNECTED TO THE PATIENT¿S FINGER, THE SPO2 CHANNEL SIGNED ON WITH QUESTION MARK ¿???¿ AND SPO2 ALARM LIMITS OFF. AFTER THE SPO2 CABLE/SENSOR IS CONNECTED TO A PATIENT¿S FINGER FOR 15 SECONDS, THE SPO2 WAVEFORM WILL DISPLAY AND SPO2 ALARM LIMITS WILL AUTOMATICALLY TURN ON. THERE IS NO NEED TO MANUALLY TURN THESE FUNCTIONS ON. THE OPERATORS MANUAL STATES IN CLINICAL PARAMETERS (070-2113-02 PAGE 9-31) THAT WHEN THE MODULE IS IN THE INITIALIZATION PHASE (THE FIRST 15 SECONDS AFTER SENSOR APPLICATION) THE SPO2 VALUE DISPLAYS AS QUESTION MARK ¿???¿. SPACELABS¿ FIELD SERVICE ENGINEER EXPLAINED THE PRODUCT OPERATION TO THE CUSTOMER. THIS REPORT IS CONSIDERED FINAL AND THE MATTER IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT THE BEDSIDE MONITOR, MODEL 91390, FAILED TO HOLD THE SPO2 ALARM LIMITS DEFAULT SETTINGS. NO ONE WAS INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT'S SPO2 SATURATION LEVEL WENT DOWN TO 87% AND THE QUBE PATIENT MONITOR, MODEL 91390, DID NOT ALARM. THE CUSTOMER ALSO REPORTED THAT SPO2 ALARM DEFAULT SETTING IS NOT HOLDING. EACH TIME NEW PATIENT IS ADMITTED, SPO2 ALARM LIMITS ARE OFF. NURSES NEED TO MANUALLY ENABLE ALARM LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438973 SPACELABS QUBE COMPACT MONITOR COMPACT MONITOR MHX SPACELABS HEALTHCARE INC. 91390

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 91496 V2.02.02| 91496 (B)(4) 2.02.02