BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 2552403 · Received April 29, 2012

    Report

    Report Number
    9611451-2012-00261
    Event Type
    Malfunction
    Date Received
    April 29, 2012
    Report Date
    March 31, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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 K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT HAS BEEN RETURNED TO THE MANUFACTURER. THE BREATHING CIRCUIT WAS VISUALLY INSPECTED AND A HEATER WIRE RESISTANCE TEST WAS CARRIED OUT USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE TEST REVEALED THE EXPIRATORY LIMB TO BE WITHIN SPECIFICATION FOR THIS PRODUCT, HOWEVER THE INSPIRATORY LIMB WAS FOUND TO BE OPEN CIRCUIT. IT WAS IDENTIFIED THAT THE OPEN CIRCUIT OF THE INSPIRATORY LIMB HEATER WIRE WAS LOCATED AT THE CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE HEATER WIRE PINS INSIDE THE "OVERMOULDED" PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 100903. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION, SUCH THAT IT 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 PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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 K983112. THE COMPLAINT RT100 DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT100 ADULT BREATHING CIRCUIT CANNOT HEAT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT100 ADULT BREATHING CIRCUIT CANNOT HEAT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT100 100903

    Patients

    Seq Age Sex Outcome Treatment
    1