BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT, INSPIRATORY HEATED

    MDR report key: 1063703 · Received June 20, 2008

    Report

    Report Number
    9611451-2008-00380
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    April 4, 2008
    Report Date
    June 3, 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 DISTRIBUTOR 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 RT106 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO THE MANUFACTURER FOR INVESTIGATION. NO RESULTS AND CONCLUSIONS ARE THEREFORE AVAILABLE AT PRESENT. A FOLLOW-UP REPORT WILL BE PREPARED AND FORWARDED AS SOON AS THE BREATHING CIRCUIT IS RETURNED AND INVESTIGATION RESULTS BECOME AVAILABLE. HOWEVER, IN VIEW OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, WE NOTE THE FOLLOWING: FISHER & PAYKEL BREATHING CIRCUITS ARE DESIGNED FOR SINGLE USE OF UP TO A MAXIMUM OF 7 DAYS. THIS IS PROVIDED FOR IN OUR "USER INSTRUCTIONS" SHEET WHICH ACCOMPANIES EACH PRODUCT IN THE SECTION ENTITLED "WARNING". A POTENTIAL CAUSE FOR THE ALLEGED "BURNING SMELL" MAY BE PATIENT SECRETIONS COMING INTO CONTACT WITH SECTIONS OF THE HEATER WIRE. PENDING RECEIPT OF THE BREATHING CIRCUIT AND AN INVESTIGATION, WE ARE UNABLE TO CONFIRM THIS AT PRESENT.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT THE INSPIRATORY LIMB OF AN RT106 ADULT BREATHING CIRCUIT GAVE OFF A "BURNING SMELL" DURING USE. IT WAS FURTHER REPORTED THAT A PORTION OF THE CIRCUIT APPEARED TO BE DISCOLORED. THE CIRCUIT HAD BEEN IN USE FOR A PERIOD OF 2 WEEKS AT THE TIME OF THE EVENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT, INSPIRATORY HEATED BTT FISHER & PAYKEL HEALTHCARE LTD. RT106

    Patients

    Seq Age Sex Outcome Treatment
    1