BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 3441398 · Received October 31, 2013

    Report

    Report Number
    9611451-2013-00867
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 4, 2013
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT HC500 HUMIDIFIER AND CAREFUSION BREATHING CIRCUIT HAVE THIS WEEK BEEN RECEIVED AT FISHER & PAYKEL HEALTHCARE, (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INVESTIGATION: HC500 HUMIDIFIER. 900MR559 HEATER WIRE ADAPTOR, LOT 120621, MANUFACTURED 21 JUNE 2012. 900MR571 TEMPERATURE PROBE, LOT 110818, MANUFACTURED 18 AUGUST 2011. CAREFUSION INSPIRATORY LIMB, UNKNOWN MODEL AND LOT NUMBER - NOT MANUFACTURED BY FPH. THE FOLLOWING TESTS WERE PERFORMED: CALIBRATION AND PERFORMANCE TEST OF THE HC500. HEATER WIRE ADAPTER CONNECTION TO THE HC500. PROBE TEMPERATURE ACCURACY TEST. VISUAL INSPECTION AND RESISTANCE MEASUREMENT OF THE HEATER WIRE. RESULTS: THE HC500 PASSED ALL THE CALIBRATION AND PERFORMANCE TESTS AS PER THE HC500 TECHNICAL MANUAL. THE HC500 DID NOT ACTIVATE AN AUDIBLE AND VISUAL HEATER WIRE ADAPTOR ALARM WHEN THE 900MR559 WAS CONNECTED TO THE HC500 AND THE CABLES WIGGLED. THIS IS WITHIN SPECIFICATION. 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. THE CAREFUSION BREATHING TUBE HAD SECTIONS OF MELTED PLASTIC ALONG THE PATH OF THE HEATER WIRE, LOCATED 300MM TO 750MM FROM THE CHAMBER PORT END. THE RESISTANCE OF THE HEATER WIRE WAS MEASURED TO BE 13.5 OHMS AND THE HEATER WIRE WAS NOT OPEN CIRCUIT. 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 BREATHING CIRCUIT AND THAT THE CIRCUIT MELTED. IT WAS FURTHER REPORTED THAT THIS WAS THE SECOND TIME THIS HAS HAPPENED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN HC500 HUMIDIFIER WAS IN USE WITH A CAREFUSION BREATHING CIRCUIT AND THAT THE CIRCUIT MELTED. IT WAS FURTHER REPORTED THAT THIS WAS THE SECOND TIME THIS HAS HAPPENED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560595 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD HC500 110819

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL 900MR559 HEATER WIRE ADAPTOR| FISHER & PAYKEL 900MR571 TEMPERATURE PROBE| CAREFUSION BREATHING CIRCUIT| CAREFUSION BREATHING CIRCUIT