BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 2211069 · Received August 15, 2011

    Report

    Report Number
    9611451-2011-00486
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    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 RT212 ADULT BREATHING CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. (B)(4). THE DRYLINE OF THE COMPLAINT UNIT WAS RETURNED UNSEALED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND VISUALLY INSPECTED. IT WAS OBSERVED THAT ONE OF THE CONNECTORS WAS MISSING ON THE DRYLINE. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 110228. THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS POSSIBLE THAT ONE OF THE CONNECTORS OF THE DRYLINE WAS OMITTED DURING THE ASSEMBLY PROCESS OR THE CONNECTOR MAY HAVE FALLEN OFF DURING PATIENT SET UP. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE ONE OF THE CONNECTORS WAS MISSING FROM THE RT212 ADULT BREATHING CIRCUIT KIT. THIS WAS FOUND 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 LTD RT212 110228

    Patients

    Seq Age Sex Outcome Treatment
    1