BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3385120 · Received October 3, 2013

    Report

    Report Number
    9611451-2013-00768
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    September 3, 2013
    Report Date
    September 5, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) OF THE SIMILAR PRODUCT IS K983112. THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) OF THE SIMILAR PRODUCT IS (B)(4). METHOD: NINE RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE HOSPITAL REPORTED THAT THE COMPLAINT DEVICES WERE FROM LOTS 130507, 130508 AND 130510. HOWEVER, THE LOT INFORMATION WAS NOT PROVIDED WITH THE RETURNED DEVICES. THE RETURNED CIRCUITS WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: ALL OF THE RETURNED CIRCUITS WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAKS WERE FROM THE CONNECTION BETWEEN THE WATER TRAP LID AND BOWL. CONCLUSION: THE RT206 BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID. THE WATER TRAP BOWL AND LID CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE USER INSTRUCTIONS FOR RT206 ADULT INSPIRATORY HEATED BREATHING CIRCUIT STATE THE FOLLOWING: - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. - SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT NINE RT206 ADULT HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A PB840 VENTILATOR. THESE WERE FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT NINE RT206 ADULT HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A PB840 VENTILATOR. THESE WERE FOUND DURING THE SETUP CHECK AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500375 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 130507, 130508, 130510

    Patients

    Seq Age Sex Outcome Treatment
    1 PURITAN BENNETT 840 VENTILATOR| PURITAN BENNETT 840 VENTILATOR