BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2161055 · Received July 13, 2011

    Report

    Report Number
    9611451-2011-00414
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT105 ADULT INSPIRATORY HEATED 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. THE RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT105 ADULT INSPIRATORY HEATED 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 (B)(4). METHOD: THE COMPLAINT RT105 ADULT BREATHING CIRCUIT KIT, WHICH WAS RETURNED UNSEALED, WAS VISUALLY INSPECTED FOR MISSING COMPONENT. RESULTS: A VISUAL INSPECTION REVEALED THAT THE KITTED PARTS BAG, WHICH CONTAINS TWO ADAPTORS, WAS MISSING FROM THE RETURNED BREATHING CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110404. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. (B)(4). OUR MONITORING AND TRENDING OF MISSING OR INCORRECT BREATHING CIRCUIT COMPONENTS HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN ELBOW ADAPTOR WAS MISSING FROM THE RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT KIT. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN ELBOW ADAPTOR WAS MISSING FROM THE RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT KIT. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT105 110404

    Patients

    Seq Age Sex Outcome Treatment
    1