BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1549872 · Received November 19, 2009

    Report

    Report Number
    9611451-2009-00602
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    October 13, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE RT105 BREATHING CIRCUIT 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 RETURNED BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: OUR TESTING REVEALED THAT THERE WAS A LEAK BETWEEN THE BOWL AND LID OF THE BREATHING CIRCUIT WATER TRAP. A LOT CHECK REVEALED NO COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090730. CONCLUSION: THE RT105 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 BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION. ALL BREATHING CIRCUITS WHICH FAIL THE PRESSURE TEST ARE REJECTED. THIS SUGGESTS THAT THE LEAK DEVELOPED POST-PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE; SET APPROPRIATE VENTILATOR ALARMS. A VENTILATOR ALARM ALERTS THE USER TO A LEAK AND ALLOWS THEM TO ACT BY REPLACING THE BREATHING CIRCUIT ACCORDING TO THEIR STANDARD PROCEDURES. (B) (4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED VIA A DISTRIBUTOR THAT AN RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT HAD A LEAK AND DID NOT PASS A VENTILATOR LEAK TEST. THE REPORTED LEAK WAS DISCOVERED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 090730

    Patients

    Seq Age Sex Outcome Treatment
    1