BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2137867 · Received June 23, 2011

    Report

    Report Number
    9611451-2011-00372
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC550 RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE UNITED STATES, BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE UNITED STATES. THE 510(K) NUMBER OF THAT PRODUCT IS (B)(4). METHOD: THE COMPLAINT DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE'S (FPH) REGIONAL OFFICE IN (B)(4), WHERE IT WAS EVALUATED BY A TRAINED FPH TECHNICIAN IN ACCORDANCE WITH THE HC550 PRODUCT TECHNICAL MANUAL. RESULTS: THE DEVICE PASSED ALL THE CALIBRATION AND PERFORMANCE CHECKS REQUIRED FOR THIS PRODUCT. NO FAULT WAS FOUND WITH THE DEVICE AND IT WAS RETURNED TO THE CUSTOMER AND IS BACK IN SERVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR THE HC550 HUMIDIFIER. CONCLUSION: WE ARE UNABLE TO DETERMINE CONCLUSIVELY WHAT CAUSED THE ISSUE AS REPORTED BY THE CUSTOMER. HOWEVER, IT IS MOST LIKELY THAT THE PROBLEM WAS CAUSED BY INCORRECT SETUP OF THE BREATHING CIRCUIT, AS REPORTED BY THE CUSTOMER, (B)(6). DEVICE EVALUATED BY REGIONAL OFFICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC550 RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE UNITED STATES, BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE UNITED STATES. THE 510(K) NUMBER OF THAT PRODUCT IS K033710. THE DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT AN INFANT WAS SENT HOME FROM (B)(6) AT THE (B)(6) 2011 AND WAS ON 24-HOUR VENTILATION, USING AN HC550 RESPIRATORY HUMIDIFIER WITH CANNULA, RT235 CIRCUIT AND ELISEE 150 VENTILATOR. IT WAS FURTHER REPORTED THAT THE HUMIDIFIER DISPLAYED 55 DEGREES C WITHOUT ALARMING. THE CUSTOMER STATED THAT THE PROBLEM WAS DUE TO A CIRCUIT INVERSION ON THE VENTILATOR. WITH THE INSPIRATORY AND EXPIRATORY LIMBS CONNECTED THE WRONG WAY ROUND. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN INFANT WAS SENT HOME FROM (B)(6) HOSPITAL AT THE END OF (B)(6) 2011 AND WAS ON 24-HOUR VENTILATION, USING AN HC550 RESPIRATORY HUMIDIFIER WITH CANNULA, RT235 CIRCUIT AND ELISEE 150 VENTILATOR. IT WAS FURTHER REPORTED THAT THE HUMIDIFIER DISPLAYED 55°C WITHOUT ALARMING. THE CUSTOMER STATED THAT THE PROBLEM WAS DUE TO A CIRCUIT INVERSION ON THE VENTILATOR. WITH THE INSPIRATORY AND EXPIRATORY LIMBS CONNECTED THE WRONG WAY ROUND. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED HC550 100820

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO FISHER & PAYKEL HEALTHCARE RT235 BREATHING CIRCUIT| ELISEE 150 VENTILATOR| FISHER & PAYKEL HEALTHCARE RT235 BREATHING CIRCUIT| ELISEE 150 VENTILATOR