BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED OXYGEN THERAPY KIT

    MDR report key: 1715349 · Received June 10, 2010

    Report

    Report Number
    9611451-2010-00348
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 8, 2010
    Report Date
    May 11, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE COMPLAINT RT408 CIRCUIT KIT WAS NOT RETURNED TO US FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS:THE CUSTOMER REPORTED THAT THE RT008 ENTRAINER WAS FOUND TO BE MISSING FROM THE BREATHING CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 091202. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED COMPONENT. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. THIS CONSISTS OF A SPECIFIC PACK CARD DETAILING ALL COMPONENTS REQUIRED WHICH MUST BE DISPLAYED AT THE PACKING STATION. AFTER THE COMPONENTS ARE PACKED, THEY ARE SENT TO THE PACK BOX STATION WHERE THEY ARE WEIGHED BY A SECOND PRODUCTION LINE STAFF MEMBER OF THE PACKING STATION, USING A SET OF SCALES TO CHECK FOR MISSING PARTS BY WEIGHT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE RT008 ENTRAINER WAS MISSING FROM AN RT408 BREATHING CIRCUIT KIT. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATED OXYGEN THERAPY KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT408 091202

    Patients

    Seq Age Sex Outcome Treatment
    1