BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 1565042 · Received November 17, 2009

    Report

    Report Number
    9611451-2009-00666
    Event Type
    Malfunction
    Date Received
    November 17, 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 DISTRIBUTOR REPORTED THE LOT NUMBER OF ONE (1) OF THE BREATHING CIRCUITS (090731), BUT WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE OTHER THREE (3) BREATHING CIRCUITS. THE RT105 BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE COMPLAINT RT105 BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR ANALYSIS. WE WILL PROVIDE A F/U REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT FOUR (4) RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUITS FAILED THE LEAK TEST WITH THE MAQUET SERVO I VENTILATOR. THE ALLEGED BREATHING CIRCUIT LEAKS WERE OBSERVED BEFORE PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT105 090731

    Patients

    Seq Age Sex Outcome Treatment
    1 MAQUET SERVO I VENTILATOR