BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 1781414 · Received August 3, 2010

    Report

    Report Number
    2015691-2010-13809
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED DUE TO PATIENT INFECTION; THEREFORE THE COMPLAINT CANNOT BE CONFIRMED IN ADDITION, A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE UNIT ZEROED BUT THE PRESSURE WAVEFORM WAS UNSTABLE. -ADDITIONAL INFORMATION RECEIVED ON (07/01/10)- STATED THAT THE READINGS WERE INACCURATE OR UNSTABLE. THE CUSTOMER FELT THAT THE PRESSURE MEASUREMENT SEEMED INACCURATE FROM THE BEGINNING AND IT DID NOT SEEM THAT THE MEASUREMENT VALUE WAS AFFECTED BY THE MEDICATION. IT WAS MEASURED AT THE FEMORAL ARTERY. CUSTOMER TRIED TO MEASURE THE PRESSURE AT THE FEMORAL ARTERY OF THE OTHER LEG, BUT THE MEASUREMENT VALUE DID NOT CHANGE. AROUND 1PM, IT DID NOT SEEM LIKE IT WOULD HAVE MUCH PRESSURE OUTPUT CLINICALLY, THE BLOOD PRESSURE MEASUREMENT VALUE STARTED TO GO UP. THE CUSTOMER DID NOT FEEL THE VALUE WAS RIGHT AND CHANGED THE DEVICE TO A NON-EDWARDS BLOOD PRESSURE MONITORING KIT AFTER THE DEVICE WAS REPLACED, BLOOD PRESSURE MEASUREMENT VALUE SHOWN WAS UNDER 100MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTRAC SENSOR DISPOSABLE PRESSURE TRANSDUCER DRS EDWARDS LIFESCIENCES DR MHD8S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1