BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 2228147 · Received August 31, 2011

    Report

    Report Number
    9611451-2011-00527
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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 RT200 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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 RT200 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULT: THE VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OBSERVED ON THE COMPLAINT DEVICE. THE PRESSURE TEST REVEALED THAT THE COMPLAINT DEVICE PERFORMED WITHIN THE REQUIRED SPECIFICATION AND NO FAULT WAS FOUND ON THE BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 110321. CONCLUSION: A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. SET APPROPRIATE VENTILATOR ALARMS. THE RETURNED BREATHING CIRCUIT OPERATED CORRECTLY DURING TESTING AND THE REPORTED FAULT COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN RT200 ADULT BREATHING CIRCUIT WAS LEAKING DURING THE VENTILATOR TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN RT200 ADULT BREATHING CIRCUIT WAS LEAKING DURING THE VENTILATOR TEST. 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 RT200 110321

    Patients

    Seq Age Sex Outcome Treatment
    1