BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2919547 · Received January 17, 2013

    Report

    Report Number
    9611451-2013-00050
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 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 DEVICE IS 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 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: ONLY THE DRYLINE TUBE OF THE COMPLAINT RT206 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: NO DAMAGE WAS FOUND TO ANY PART OF THE RETURNED DRYLINE TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120524. CONCLUSION: WE COULD FIND NO FAULT WITH THE DRYLINE TUBE AND COULD THEREFORE NOT DETERMINE THE CAUSE OF THE LEAK REPORTED BY THE CUSTOMER. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT206 BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT206 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A VENTILATOR. THEY FURTHER REPORTED THAT A PIN HOLE WAS FOUND ON THE DRY LINE TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT206 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A VENTILATOR. THEY FURTHER REPORTED THAT A PIN HOLE WAS FOUND ON THE DRY LINE TUBE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26169 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 120524

    Patients

    Seq Age Sex Outcome Treatment
    1