BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 3033132 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19721
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. LOT NUMBER WAS NOT PROVIDED; THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "MEASUREMENT VALUE WAS ABNORMAL DURING USE. ANOTHER SENSOR WAS USED AND THE PROBLEM WAS SOLVED." ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO PROBLEM ZEROING. THE ARTERIAL PRESSURE VALUE WAS SHOWING 20MMHG TO 30MMHG LOWER THAN THAT OF A ARGON DPT MEASUREMENT VALUE. THERE WAS NO PROBLEM WITH THE SHAPE OF THE WAVEFORM AND IT IS UNKNOWN WHETHER THE MEASUREMENT VALUE AND THE WAVEFORM MATCHED SINCE THE CUSTOMER DID NOT CHECK IT. IT SEEMED LIKE THERE WERE NO ERROR MESSAGES SHOWN ON THE MONITOR. MEASUREMENT DATA IS NOT AVAILABLE. THERE WERE NO KINKS, LEAKAGE OR OCCLUSION OBSERVED ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135597 FLOTRAC SENSOR TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES DR MHD6S

    Patients

    Seq Age Sex Outcome Treatment
    1