BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2192368 · Received August 4, 2011

    Report

    Report Number
    9611451-2011-00475
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT204 ADULT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS (B)(4). METHOD: THE COMPLAINT INSPIRATORY LIMB OF THE BREATHING CIRCUIT WAS RETURNED AND THE ELECTRICAL RESISTANCE OF THE HEATER WIRE WAS TESTED USING A MULTIMETER. A CONTINUITY TEST WAS USED TO LOCATE THE BREAK IN THE HEATER WIRE. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE WAS OPEN CIRCUIT. THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND HEATER WIRE PIN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, SUCH THAT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE (B)(4) ADULT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. (B)(4). THE COMPLAINT DEVICE HAS RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND EVALUATION IS ANTICIPATED. WE WILL PROVIDE A FOLLOW UP UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN (B)(4) ADULT DUAL-HEATED BREATHING CIRCUIT GENERATED A "LOW HUMIDITY ALARM" ON THE HUMIDIFIER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT204 ADULT DUAL-HEATED BREATHING CIRCUIT GENERATED A "LOW HUMIDITY ALARM" ON THE HUMIDIFIER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT204 100125

    Patients

    Seq Age Sex Outcome Treatment
    1