BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1501757 · Received September 9, 2009

    Report

    Report Number
    9611451-2009-00489
    Event Type
    Malfunction
    Date Received
    September 9, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 19, 2009
    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

    (B)(4). THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE INSPIRATORY TUBE OF THE RETURNED RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR BENT PINS AND TESTED TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A VISUAL INSPECTION REVEALED THAT THE LEFT HEATER WIRE PIN WAS BENT. THIS PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET. A HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE INSPIRATORY TUBE HEATER WIRE PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR PRODUCTS WITH LOT NUMBER 090709. CONCLUSION: IT IS POSSIBLE FOR THE USER TO BEND THE HEATER WIRE PINS IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG AT AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THEY WERE UNABLE TO CONNECT AN ADAPTOR TO AN RT105 ADULT INSPIRATORY HEATED BREATHING CIRCUIT "BECAUSE THE CONNECTION WAS TOO TIGHT." THE REPORTED CONNECTION ISSUE WAS DISCOVERED BEFORE USE, THEREFORE THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD RT105 090709

    Patients

    Seq Age Sex Outcome Treatment
    1