BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1841804 · Received September 22, 2010

    Report

    Report Number
    9611451-2010-00569
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE MR850 HUMIDIFIER, TEMPERATURE PROBE AND HEATER WIRE ADAPTOR WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE'S US OFFICE AND VISUALLY INSPECTED. NO BREATHING CIRCUIT WAS RECEIVED FOR INVESTIGATION. THE HUMIDIFIER WAS TEST RUN FOR THREE HOURS. THE RETURNED HUMIDIFIER AND TEMPERATURE PROBE WERE ALSO TEST-CHECKED ACCORDING TO THE RELEVANT PRODUCT TECHNICAL MANUAL. RESULTS: NO DAMAGE WAS NOTED TO ANY OF THE THREE DEVICES. NO ABNORMAL OPERATION WAS NOTICED DURING THE TEST RUN AND NO BOILING WATER WAS OBSERVED. THE UNIT WAS ABLE TO CONTROL TEMPERATURE CORRECTLY AND DID NOT OVERHEAT. BOTH HUMIDIFIER AND PROBE PASSED ALL THE FUNCTIONAL CHECKS AND NO FAULT WAS FOUND WITH HUMIDIFIER, PROBE OR HEATER WIRE ADAPTOR. CONCLUSION: WITHOUT THE RETURN OF THE BREATHING CIRCUIT THE FAILURE MODE COULD NOT BE CONFIRMED. WE ARE THUS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. DEVICE EVALUATED AT OUR US OFFICE.

    Additional Manufacturer Narrative · 1

    WE ARE STILL ENDEAVOURING TO RETRIEVE THE COMPLAINT DEVICES FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT ON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 HUMIDIFIER OVERHEATED AND THAT THE WATER WAS "BOILING WHILE ON A PATIENT". THEY FURTHER STATED THAT THOUGH THE TEMPERATURE WAS LOW, 33 DEGREES CENTIGRADE, WATER WAS BOILING AND THE CIRCUIT WAS MELTING. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 HUMIDIFIER OVERHEATED AND THAT THE WATER WAS "BOILING WHILE ON A PATIENT". THEY FURTHER STATED THAT THOUGH THE TEMPERATURE WAS LOW, 33 DEGREES CENTRIGRADE, WATER WAS BOILING AND THE CIRCUIT WAS MELTING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 090814

    Patients

    Seq Age Sex Outcome Treatment
    1 900MR805 HEATER WIRE ADAPTOR| RT110 BREATHING CIRCUIT| RT110 BREATHING CIRCUIT| 900MR805 HEATER WIRE ADAPTOR| PB840 VENTILATOR| PB840 VENTILATOR