BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR VITAL SIGNS MONITOR

    MDR report key: 1676458 · Received April 28, 2010

    Report

    Report Number
    2248049-2010-00003
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    December 4, 2008
    Report Date
    April 29, 2010
    Manufacturer
    SMITHS MEDICAL PM, INC
    Product Code
    DQK
    PMA / PMN Number
    K030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: ST JUDE MEDICAL INTEGRATES THE SMITH ADVISOR MONITOR INTO ITS NURSEMATE WITH PHYSIO SYS VIA K070706. SJM DOES NOT MODIFY THE ADVISOR IN ANY WAY: NURSEMATE RECORDS THE TABULAR DATA OUTPUT BY THE ADVISOR. CLINICIANS UTILIZE THE ADVISOR'S DISPLAY, ALARMS AND CONTROLS DIRECTLY. (B)(4), 2009, SJM COMPLETED TRAINING AT (B)(4) ON THE PROPER USE OF THE SMITHS ADVISOR. THERE HAVE BEEN NO FURTHER PROBLEMS REPORTED. TWO MDRS FILED (B)(4) 2008 (2248049-2008-00005 AND 2248049-2008-00006) LIST THREE DEVICES WITH SAME PROBLEM. THIS REPORT IS BEING FILED TO SPECIFY THE DEVICE SERIAL NUMBER ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    WHEN USED AS PART OF THE NURSEMATE WITH PHYSIO SYSTEM, DURING CARDIAC ELECTROPHYSIOLOGY CASES, THE SMITHS MEDICAL ADVISOR VITAL SIGNS MONITOR REPORTEDLY DISPLAYED INACCURATE BLOOD OXYGEN SATURATION LEVELS (SPO2) AND NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS WHILE PTS WERE EXPERIENCING CARDIAC ARRHYTHMIAS. THE HOSP DID NOT PROVIDE PT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVISOR VITAL SIGNS MONITOR VITAL SIGNS MONITOR DQK SMITHS MEDICAL PM, INC 9200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK