BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1963200 · Received January 18, 2011

    Report

    Report Number
    9611451-2011-00041
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE RT100 IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER FOR THAT PRODUCT IS K983112. METHOD: THE RETURNED BREATHING CIRCUIT KIT (UNSEALED) WAS VISUALLY INSPECTED FOR MISSING COMPONENTS. RESULTS: THE DRYLINE, STRAIGHT ADAPTOR AND ELBOW ADAPTOR WERE FOUND TO BE MISSING FROM THE CIRCUIT KIT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF A MISSING DRYLINE FOR LOT NUMBER 100119. NO OTHER COMPLAINTS OF MISSING CONNECTORS HAVE BEEN RECEIVED FOR LOT NUMBER 100119. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS POSSIBLE THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED DRYLINE, STRAIGHT ADAPTOR AND ELBOW ADAPTOR. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THE ADAPTOR KIT AND DRYLINE WERE MISSING FROM AN RT100 BREATHING CIRCUIT KIT. THE DISTRIBUTOR NOTICED THAT THE COMPONENTS WERE MISSING PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT100 100119

    Patients

    Seq Age Sex Outcome Treatment
    1