BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR VITAL SIGNS MONITOR

    MDR report key: 3004205 · Received December 24, 2008

    Report

    Report Number
    2248049-2008-00002
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    December 4, 2008
    Report Date
    December 23, 2008
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    CCK
    PMA / PMN Number
    K030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: SAINT JUDE MEDICAL (SJM) INTEGRATES THE SMITHS ADVISOR MONITOR INTO IT'S NURSMATE WITH PHYSIO SYSTEM 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 AND CONTROLS DIRECTLY. TWO SMITHS ADVISORS ARE LOCATED AT (B)(6): SNS: (B)(4).

    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 PURPORTEDLY DISPLAYED INACCURATE NOINVASIVE BLOOD PRESSURE (NIBP) WHILE PATIENTS WERE EXPERIENCING CARDIAC ARRHYTHMIAS. THE ADVISOR INSTRUCTIONS FOR USE (IFU) PROVIDE A CLEAR WARNING REGARDING THIS RESULT ON THE NIBP CHANNEL. THE HOSPITAL HAS THUS FAR REFUSED TO RELEASE THE PATIENT DATA REQUIRED ABOVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1