BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1883591 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00638
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF MANUFACTURE: LOT NUMBER: 100110, DATE OF MANUFACTURE: 01/10/2010; LOT NUMBER: 100116, DATE OF MANUFACTURE: 01/16/2010. THE 510(K) NUMBER: THE RT204 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. NARRATIVE: THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE CIRCUITS AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DATE OF MANUFACTURE: LOT NUMBER: 100110, DATE OF MANUFACTURE: 01/10/2010. LOT NUMBER: 100116, DATE OF MANUFACTURE: 01/16/2010. 510(K) NUMBER: THE RT204 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. NARRATIVE: METHOD: THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN THE INSPIRATORY AND EXPIRATORY TUBES OF THE RETURNED RT204 ADULT DUAL HEATED BREATHING CIRCUITS WAS TESTED USING A MULTIMETER. RESULTS: THE RESISTANCE OF THE INSPIRATORY AND EXPIRATORY TUBES OF ALL THREE BREATHING CIRCUITS WAS WITHIN SPECIFICATION. CONCLUSION: THE REPORTED FAULT COULD NOT BE REPLICATED AS THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN THE THREE BREATHING CIRCUITS WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE RESISTANCE OF THE EXPIRATORY HEATER WIRE WAS HIGH IN THREE (3) RT204 ADULT DUAL-HEATED BREATHING CIRCUITS. THE BREATHING CIRCUITS WERE TESTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE RESISTANCE OF THE EXPIRATORY HEATER WIRE WAS HIGH IN THREE (3) RT204 ADULT DUAL-HEATED BREATHING CIRCUITS. THE BREATHING CIRCUITS WERE TESTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT204 100110 (1), 100116 (2)

    Patients

    Seq Age Sex Outcome Treatment
    1