BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1813087 · Received August 15, 2010

    Report

    Report Number
    9611451-2010-00490
    Event Type
    Malfunction
    Date Received
    August 15, 2010
    Report Date
    July 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT210 BREATHING CIRCUITS ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEAL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: WITHOUT A COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. CONCLUSION: BEFORE LEAVING PRODUCTION, ALL BREATHING CIRCUITS ARE TESTED FOR ELECTRICAL RESISTANCE, LEAKAGE AND CONNECTIVITY. THOSE THAT FAIL ARE REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT210 ADULT BREATHING CIRCUIT CAUSED A VENTILATOR ALARM WHEN CONNECTED TO A VENTILATOR DURING PATIENT USE. THREE OTHER BREATHING CIRCUITS WERE TRIED WITH THE SAME OUTCOME. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT210 100409

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR