BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPERATURE/FLOW PROBE

    MDR report key: 1674508 · Received April 30, 2010

    Report

    Report Number
    9611451-2010-00258
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE #2: LOT# 090618; DATE OF MFR: 06/18/2009. BACKGROUND: THE TEMPERATURE/FLOW PROBE IS A REUSABLE DEVICE INSERTED INTO THE BREATHING CIRCUIT WHICH SENDS TEMPERATURE AND FLOW INFO BY WAY OF ELECTRICAL FEEDBACK TO THE MR850 HUMIDIFIER. METHOD: THE TWO (2) COMPLAINT PROBES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CTR IN (B)(4). THE PROBES WERE TESTED FOR PERFORMANCE AND FUNCTIONALITY. RESULTS: TESTING REVEALED THAT THE FLOW THERMISTOR, WHICH TAKES MEASUREMENTS AT THE HUMIDIFICATION CHAMBER, OF THE FIRST PROBE WAS NOT WORKING CORRECTLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT # 090109. THE SECOND PROBE FUNCTIONED PROPERLY DURING TESTING. CONCLUSION: A FAULTY FLOW THERMISTOR WILL CAUSE THE HEATER BASE TO READ HIGHER THAN THE ACTUAL TEMPERATURE AND DROP AND THE HEAT SETTING. THE REDUCED TEMPERATURE SETTING WILL THEN RESULT IN THE CONDENSATION REPORTED BY THE HOSP. THE FAULTY PROBE HAS BEEN REPLACED. NO FAULT WAS FOUND WITH THE SECOND PROBE. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED THAT THEY ARE HAVING PROBLEMS WITH CONDENSATION. THE HOSP REPORTED THAT THEY BELIEVE THAT THE RAINOUT IS CAUSING INACCURATE MINUTE VOLUME READINGS ON THE VENTILATOR. THE HOSP REQUESTED THAT TWO (2) 900MR869 TEMPERATURE/FLOW PROBES BE TESTED FOR ACCURACY. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE/FLOW PROBE BTT FISHER & PAYKEL HEALTHCARE, LTD. 900MR869 090109

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| UNK THIRD-PARTY VENTILATOR| FISHER & PAYKEL HEALTHCARE RT200 BREATHING CIRCUIT