BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2022881 · Received March 17, 2011

    Report

    Report Number
    9611451-2011-00171
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 16, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT HUMIDIFIER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR TESTING. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HC500 RESPIRATORY HUMIDIFIER WAS RECEIVED AT OUR US DISTRIBUTION OFFICE IN (B)(4), WHERE IT WAS VISUALLY EXAMINED AND PERFORMANCE TESTED BY A TRAINED TECHNICIAN. FISHER & PAYKEL HEALTHCARE HAS NOT BEEN ADVISED OF THE TYPE OF CIRCUIT IN USE AT THE TIME. RESULTS: THE VISUAL CHECK REVEALED THAT THERE WAS NO VISIBLE DAMAGE TO THE UNIT. THE HUMIDIFIER PASSED ALL CALIBRATION AND PERFORMANCE CHECKS, AND NO ALARMS WERE NOTED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: NO FAULT WAS FOUND WITH THE HC500 RESPIRATORY HUMIDIFIER. THE MAXIMUM TEMPERATURE SETTING ON THE HC500 IS 39 DEGREES CELSIUS. THE GAS THEN FLOWS THROUGH THE BREATHING CIRCUIT AND A PATIENT INTERFACE, BY WHICH TIME, BASED ON NORMAL OPERATING CONDITIONS, THE TEMPERATURE OF THE GAS ENTERING THE PATIENT WILL BE AT MOST 37 DEGREES CELSIUS. FISHER & PAYKEL THEREFORE CONSIDERS IT VERY UNLIKELY THAT THE DEVICE CAUSED THE SYMPTOMS. FISHER & PAYKEL UNDERSTAND THE PATIENT HAS SUBSEQUENTLY CONTINUED WITH THE TREATMENT AND HAS BEEN ADVISED EVERYTHING IS "GOING WELL".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A PATIENT HAD BEEN TAKEN TO THE HOSPITAL WITH "PNEMONIA-LIKE SYMPTOMS", ALLEGEDLY POSSIBLY CAUSED BY THE HIGH TEMPERATURE OF GAS WHILE IT WAS IN THE PATIENT'S AIRWAY. IT WAS REPORTED THAT THE PATIENT HAS BEEN ON A SETUP WHICH INCLUDED AN HC500 RESPIRATORY HUMIDIFIER AND THAT THE SETTING ON THE HUMIDIFIER HAD BEEN MANUALLY INCREASED TO THE MAXIMUM LEVEL DURING USE BY THE PATIENT'S NURSE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN TEXAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A PATIENT HAD BEEN TAKEN TO THE HOSPITAL WITH "PNEMONIA-LIKE SYMPTOMS" AND THAT IT WAS BELIEVED THE CONDITION WAS RELATED TO "SLOUGHING IN THE LUNGS". IT WAS REPORTED THAT THE PATIENT HAS PREVIOUSLY BEEN ON A SETUP WHICH INCLUDED AN HC500 RESPIRATORY HUMIDIFIER AND THAT THE SETTING ON THE HUMIDIFIER HAD BEEN MANUALLY INCREASED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED HC500JHU 091012

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention