BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 3875726 · Received June 16, 2014

    Report

    Report Number
    9611451-2014-00529
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN THE COMPLAINT HC500 HUMIDIFIER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    METHOD: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INVESTIGATION: - HC500 HUMIDIFIER, - 900MR900 HEATER WIRE ADAPTOR, LOT 130816, MANUFACTURED 16 AUGUST 2013, - 900MR561 TEMPERATURE PROBE, LOT 130912, MANUFACTURED 12 SEPTEMBER 2013. THE FOLLOWING TESTS WERE PERFORMED: 1) CALIBRATION AND PERFORMANCE TEST OF THE HC500. 2) HEATER WIRE ADAPTER CONNECTION TO THE HC500. 3) PROBE TEMPERATURE ACCURACY TEST. 4) VISUAL INSPECTION AND RESISTANCE MEASUREMENT OF THE HEATER WIRE. RESULTS: 1) THE HC500 PASSED ALL THE CALIBRATION AND PERFORMANCE TESTS AS PER THE HC500 TECHNICAL MANUAL. 2) THE HC500 DID NOT ACTIVATE AN AUDIBLE AND VISUAL HEATER WIRE ADAPTOR ALARM WHEN THE 900MR561 WAS CONNECTED TO THE HC500 AND THE CABLES WIGGLED. THIS IS WITHIN SPECIFICATION. 3) THE HC500 DID NOT ACTIVATE AN AUDIBLE AND VISUAL TEMPERATURE PROBE ALARM WHEN THE CABLES WERE WIGGLED. BOTH THE CHAMBER THERMISTOR AND AIRWAY THERMISTOR WERE WITHIN SPECIFICATION. CONCLUSION: NO FAULT WAS FOUND WITH ANY OF THE RETURNED FPH DEVICES. THE BREATHING CIRCUIT WAS NOT MANUFACTURED BY FISHER & PAYKEL HEALTHCARE, SO WE ARE UNABLE TO COMMENT ON THE PERFORMANCE OF THE CIRCUIT. THE HC500 USER MANUAL CONTAINS THE FOLLOWING WARNINGS: - TO PREVENT THE POSSIBILITY OF ACCIDENTAL PATIENT BURNS, ENSURE THAT THE HEATED BREATHING CIRCUIT IS NOT IN CONTACT WITH THE PATIENT'S SKIN. - USE ONLY FISHER & PAYKEL APPROVED CHAMBERS, CIRCUITS AND ACCESSORIES. PERFORMANCE AND SAFETY CANNOT BE GUARANTEED IF OTHER TYPES OF ACCESSORIES ARE USED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN HC500 HUMIDIFIER WAS IN USE WITH A CAREFUSION 15091-04 BREATHING CIRCUIT AND THAT THE CIRCUIT MELTED. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN HC500 HUMIDIFIER WAS IN USE WITH A CAREFUSION 15091-04 BREATHING CIRCUIT AND THAT THE CIRCUIT MELTED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351992 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD HC500 130821

    Patients

    Seq Age Sex Outcome Treatment
    1 CAREFUSION BREATHING CIRCUIT| CAREFUSION BREATHING CIRCUIT