BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BIPAP / CPAP BREATHING CIRCUIT KIT

    MDR report key: 1203452 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00618
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RT139 BREATHING CIRCUIT KITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE. WE HAVE ASSESSED THIS EVENT BASED ON ANALYSIS OF EVENTS OF A SIMILAR NATURE. RESULTS: THE RT139 BREATHING CIRCUIT KITS ARE SOLD IN BOXES OF 10 UNITS CONTAINING 1 INSTRUCTION SHEET PER BOX. ACCORDING TO THE EVENT DESCRIPTION AS REPORTED, INSTRUCTION WERE FOUND MISSING FROM 2 BOXES OF RT139 BREATHING CIRCUIT KITS. CONCLUSION: THE OMISSION OF 2 INSTRUCTION SHEETS FOR THESE DEVICES IS MOST LIKELY DUE TO OPERATOR ERROR DURING THE PACKING PROCESS. BOTH BOXES OF BREATHING CIRCUITS APPEAR TO HAVE ALSO PASSED VISUAL INSPECTION FOR MISSING COMPONENTS. A LOT CHECK COULD NOT BE PERFORMED, AS NO LOT NUMBERS HAVE BEEN PROVIDED. OUR MONITORING AND TRENDING OF EVENTS INVOLVING MISSING AND INCORRECT COMPONENTS IN BREATHING CIRCUITS HAS A LOWEST RATE OF OCCURRENCE WORLDWIDE IN THE LAST YEAR TO SEPTEMBER 2008.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT THE INSTRUCTION SHEETS WERE MISSING FROM 2 BOXES, EACH CONTAINING 10 UNITS OF RT139 ADULT BIPAP / CPAP BREATHING CIRCUIT KITS. THIS EVENT OCCURRED BEFORE PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BIPAP / CPAP BREATHING CIRCUIT KIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT139

    Patients

    Seq Age Sex Outcome Treatment
    1