BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1940013 · Received December 28, 2010

    Report

    Report Number
    9611451-2010-00798
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 24, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). 510(K) NUMBER: THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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. MANUFACTURER NARRATIVE: METHOD: THE COMPLAINT DEVICE, AS WELL AS PHOTOGRAPHS OF THE COMPLAINT DEVICE, WERE VISUALLY INSPECTED. RESULTS: THE PRODUCT LABEL WAS MISSING FROM THE PACKAGING ON THE BREATHING CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101117. CONCLUSION: THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR, DURING THE PACKING PROCESS, RESULTED IN THE PRODUCT LABEL BEING OMITTED FROM THE BREATHING CIRCUIT KIT. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) HAVE BEEN PUT IN PLACE TO ASSIST THE OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. INSTRUCTIONS INCLUDE PACKING THE CIRCUITS 'TOP AND TAIL' ALTERNATELY, WITH LABELS FACING AWAY FROM THE FRONT OF THE BOX. HOWEVER, IN THIS INSTANCE, THE MISSING LABEL WAS OVERLOOKED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT212 BREATHING CIRCUIT WAS RECEIVED WITHOUT A LABEL. THE DISTRIBUTOR OBSERVED THAT THE LABEL WAS MISSING ON THE PRODUCT 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 RT212 101117

    Patients

    Seq Age Sex Outcome Treatment
    1