BEUDAMED
    FDA Adverse Event Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1947266 · Received January 4, 2011

    Report

    Report Number
    9611451-2011-00015
    Date Received
    January 4, 2011
    Report Date
    December 3, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT HUMIDIFIERS, BOTH WITH LOT NUMBER 021121, ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. ATTEMPTS TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE COMPLAINT HAVE BEEN UNSUCCESSFUL. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL FURTHER REPORTED THAT AFTER 30 MINUTES WARM UP TIME THE AIRWAY TEMPERATURES FOR EACH UNIT WERE 30.4 DEGREES CELSIUS AND 31.9 DEGREES CELSIUS RESPECTIVELY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE MR730 RESPIRATORY HUMIDIFIER IS DESIGNED FOR USE IN HOSPITALS TO WARM AND HUMIDIFY RESPIRATORY GASES DELIVERED TO PATIENTS REQUIRING MECHANICAL VENTILATION. THE HUMIDIFIER IS USED IN CONJUNCTION WITH THE TEMPERATURE PROBE AND HEATER WIRE ADAPTER TO CONTROL THE LEVEL OF HUMIDITY DELIVERED TO PATIENTS. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS SINCE VISITED THE HOSPITAL AND ADVISED THAT THE RESPIRATORY MANAGER NO LONGER WORKS AT THE FACILITY AND THAT ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE REPORTING NURSE HAVE BEEN UNSUCCESSFUL. WITHOUT A COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. HOWEVER, IT IS UNLIKELY THAT THE BABY BECAME "TOO HOT" WITH THE REPORTED TEMPERATURES FROM THE HOSPITAL, AS THE HUMIDIFIER IS EXPECTED TO DELIVER A TEMPERATURE OF 37 DEGREES CELSIUS. IT IS POSSIBLE THAT THIS MAY HAVE BEEN CAUSED BY A SET UP ISSUE. THE MR730 RESPIRATORY HUMIDIFIER HAS SEVERAL SAFETY FEATURES, INCLUDING AN AUDIBLE AND VISUAL ALARM, WHICH ALERT THE USER IF THE MEASURED TEMPERATURE EXCEEDS 41°CELSIUS AND DISABLES THE HEATER. THE HUMIDIFIER ALSO HAS A THERMAL CUTOUT ON THE HEATER PLATE WHICH LIMITS THE MAXIMUM TEMPERATURE OF THE GAS ENTERING THE SYSTEM. THE TECHNICAL MANUAL ADVISES THAT THE OPERATION AND CALIBRATION OF THE DEVICE "SHOULD BE PERFORMED AFTER ANY SERVICING, AND ANNUALLY AS PART OF THE ROUTINE MAINTENANCE PROCEDURE" TO ENSURE FUNCTIONALITY. OUR REPRESENTATIVE HAS BEEN WORKING WITH THE HOSPITAL TO MITIGATE ANY SETUP/ENVIRONMENTAL PROBLEMS THEY MAY BE ENCOUNTERING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(46 REPORTED THAT TWO MR730 RESPIRATORY HUMIDIFIERS "SEEM TO MAKE THE BABY WAY TOO HOT, CAUSING THE RESPIRATORY RATE TO INCREASE". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE MR730 RESPIRATORY HUMIDIFIER "SEEMS TO MAKE THE BABY WAY TOO HOT, CAUSING THE RESPIRATORY RATE TO INCREASE." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR730JHU 021121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention