BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2248925 · Received September 14, 2011

    Report

    Report Number
    9611451-2011-00571
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Report Date
    August 16, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 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 K20332. ADDITIONAL LOT DATES: 100303 - 2 UNITS. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARDS TO THE COMPLAINT DEVICES. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 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 K20332. METHOD: A TOTAL OF (B)(4) INSPIRATORY LIMBS OF THE COMPLAINT RT225 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE INSPIRATORY LIMBS OF ALL COMPLAINT DEVICES WERE PERFORMANCE TESTED. RESULT: FULL INSERTION OF THE INSPIRATORY HEATER WIRE ADAPTER WAS ACHIEVED FOR 2 COMPLAINT DEVICES AND NO FAULT WAS FOUND FOR BOTH DEVICES. FULL INSERTION OF THE INSPIRATORY HEATER WIRE ADAPTER WAS NOT ACHIEVED FOR THE REMAINING 2 COMPLAINT DEVICES, WHERE BOTH DEVICES WERE FOUND TO HAVE BENT INSPIRATORY HEATER WIRE PINS. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS ABLE TO BE CONFIRMED FROM THE RETURNED COMPLAINT DEVICES. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO BEND OR SPLIT THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT PINS REPORTED TO US, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT OR SPLIT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMERS THAT THE INSPIRATORY LIMB HEATER WIRE CONNECTORS OF 4 RT225 INFANT BIAS FLOW BREATHING CIRCUITS WERE DAMAGED. THESE WERE FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMERS THAT THE INSPIRATORY LIMB HEATER WIRE CONNECTORS OF 4 RT225 INFANT BIAS FLOW BREATHING CIRCUITS WERE DAMAGED. THESE WERE FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 091023

    Patients

    Seq Age Sex Outcome Treatment
    1