BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1040836 · Received May 9, 2008

    Report

    Report Number
    9611451-2008-00236
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    March 13, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL IN ANOTHER COUNTRY, THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE HEATER WIRE IN THE RETURNED INSPIRATORY LIMB WAS ELECTRICALLY TESTED AND VISUALLY INSPECTED. THE HEATER WIRE WAS FOUND TO BE AN OPEN CIRCUIT. VISUAL INSPECTION ALSO REVEALED THE HEATER WIRE WAS CUT NEAR THE HEATER WIRE PLUG. CONCLUSION: ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS LIKELY THAT THE SMALL CUT OCCURRED DURING PRODUCTION, WEAKENING THE HEATER WIRE SUFFICIENTLY TO CAUSE IT TO BREAK ON VENTILATOR SETUP. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOW A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST YEAR OF 0.0015 %.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT THE HEATER WIRE ALARM SOUNDED ON AN RT204 ADULT BREATHING CIRCUIT AS SOON AS THE VENTILATOR STARTED WORKING. IT WAS ALSO REPORTED THAT THE RT204 ADULT BREATHING CIRCUIT WAS REPLACED AND NO FURTHER PROBLEMS OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT204

    Patients

    Seq Age Sex Outcome Treatment
    1