BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS SENSIS

    MDR report key: 641314 · Received July 21, 2005

    Report

    Report Number
    641314
    Event Type
    Malfunction
    Date Received
    July 21, 2005
    Date of Event
    October 13, 2004
    Report Date
    July 21, 2005
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SIEMENS SENSIS SYSTEM LOCATED IN OUR CATH LABS UTILIZES NONIN MEDICAL INC. PULSE OXIMETRY REUSABLE FINGER SENSORS. THE CABLE CONNECTOR CONFIGURATION ON THE SIEMENS SUPPLIED PRODUCT IS SUCH THAT A NELLCOR-TYPE SENSOR CAN BE CONNECTED TO THAT CABLE. CATH LAB PERSONNEL HAVE STATED THAT WHEN THE NELLCOR FINGER SENSOR IS CONNECTED TO THE SIEMENS CABLE THE PATIENT OXYGEN SATURATION PERCENTAGES HAVE BEEN INACCURATE. THIS WAS CONFIRMED WHEN THE NELLCOR FINGER SENSOR WAS CONNECTED TO AN EQUIPMENT PRODUCT THAT HAS THE NELLCOR CIRCUITRY AS ITS STANDARD COMPONENT. NONIN MEDICAL HAS BEEN CONTACTED CONCERNING THE ISSUE OF THE POSSIBLE CONNECTION OF NELLCOR PRODUCTS TO THEIR CABLES. THEY STATED THAT THERE WAS A COMPATIBILITY ISSUE AND THAT THIS PRACTICE SHOULD NOT BE DONE. THIS COULD LEAD TO INACCURATE OXYGEN SATURATION READINGS. NONIN TECHNOLOGY IS NOT UP TO DATE TO SAFELY DISPLAY LOW PERFUSION PATIENT, HIGH MOTION, AND LIGHT INTERFERNCE. MASIMO AND NELLCOR HAVE MET THIS NEED. SIEMENS SAYS THE NELLCOR SENSOR IS NOT COMPATIBLE BUT WILL NOT RELEASE A LETTER SAYING SO. WE ARE USING A STAND ALONE PULSE OXIMETRY SYSTEM BUT WHAT WE NEED IS THIS SYSTEM TIED TOGETHER AND ALL INFORMATION DOCUMENTED ON ONE RECORD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS SENSIS HEMODYNAMIC AND ELECTROPHYSIOLOGICAL RECORDING SYSTEM MHX SIEMENS MEDICAL SOLUTIONS USA, INC. * *
    2 * PULSE OXIMETRY CABLE DQA NONIN MEDICAL, INC. * *
    3 * PULSE OXIMETRY FINGER SENSOR DQA NELLCOR PURITAN BENNETT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *