BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1933529 · Received December 20, 2010

    Report

    Report Number
    9611451-2010-00769
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS MANUFACTURED IN 2000. A SECOND DEVICE WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR TESTING. THE SECOND DEVICE THAT WAS RETURNED HAD SERIAL NUMBER (B)(4) AND WAS ALSO MANUFACTURED IN 2000. FISHER & PAYKEL HEALTHCARE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER IN REGARDS TO THE REPORTED COMPLAINT. THE HOSPITAL ADVISED THAT THE OUTPUT TEMPERATURE FROM THE HUMIDIFIER WAS SET TO 27° CELSIUS AND THAT THE DISPLAY SHOWED THE DELIVERY TEMPERATURE WAS ALSO 27° CELSIUS. THE HOSPITAL ALSO REPORTED THAT THE "MR730 IS PROPERLY CALIBRATED AND PASSES ALL PERFORMANCE CHECKS". TWO HUMIDIFIERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTRE IN (B)(4) FOR TESTING AS THE HOSPITAL WAS UNABLE TO CONFIRM WHICH DEVICE WAS USED IN THE PATIENT SETUP. THE HUMIDIFIERS WERE VISUALLY INSPECTED FOR DAMAGE AND WERE TESTED FOR FUNCTIONALITY. BOTH HUMIDIFIERS WERE FOUND TO HAVE EXTERNAL PHYSICAL DAMAGE, HOWEVER BOTH DEVICES PASSED ALL PERFORMANCE AND CALIBRATION CHECKS. NO FUNCTIONAL FAULTS WERE FOUND WITH EITHER HUMIDIFIER. THIS IS CONSISTENT WITH THE TEST RESULTS PROVIDED BY THE HOSPITAL. THE ROOT CAUSE OF THE REPORTED FAULT CANNOT BE DETERMINED, HOWEVER THE HOSPITAL HAS ADVISED THAT THE REPORTED INJURY HAS HEALED. IT IS UNLIKELY THAT THE INJURY ON THE PATIENT'S NOSE WAS A BURN AS A DELIVERY TEMPERATURE OF 27° CELSIUS, TEN DEGREES BELOW BODY TEMPERATURE, WILL NOT CAUSE THERMAL INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS MANUFACTURED IN 2000. FISHER & PAYKEL HEALTHCARE HAS RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER IN REGARDS TO THE REPORTED COMPLAINT. IN ADDITION, THE COMPLAINT HUMIDIFIER HAS BEEN RECEIVED AT FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). OUR INVESTIGATION IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A PATIENT WHO WAS RECEIVING OXYGENOTHERAPY IN A SETUP WHICH INCLUDED A BREATHING CIRCUIT (MODEL AND MANUFACTURER UNKNOWN), A FISHER & PAYKEL HEALTHCARE NASAL HIGH FLOW INTERFACE AND A FISHER & PAYKEL HEALTHCARE MR730 RESPIRATORY HUMIDIFIER HAD A "SECOND-DEGREE BURN AT THE ENTRANCE OF THE NOSTRIL".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A PATIENT WHO WAS RECEIVING OXYGENOTHERAPY IN A SETUP WHICH INCLUDED BREATHING CIRCUIT (MODEL AND MANUFACTURER UNKNOWN), A NASAL HIGH FLOW INTERFACE AND AN MR730 RESPIRATORY HUMIDIFIER HAD A SECOND DEGREE BURN ON ITS NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR730ASU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE BC SERIES INTERFACE| UNKNOWN BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE BC SERIES INTERFACE