BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATING CIRCUIT

    MDR report key: 1842083 · Received August 26, 2010

    Report

    Report Number
    9611451-2010-00518
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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: A COMPLAINT DEVICE WAS RECEIVED AND PRESSURE TESTED. RESULTS: A PRESSURE TEST REVEALED THAT THE PRESSURE OF THE COMPLAINT DEVICE WAS WITHIN ACCEPTABLE SPECIFICATIONS FOR THIS PRODUCT. CONCLUSION: NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE. ALL BREATHING CIRCUITS MUST PASS A FINAL PRESSURE TEST ON THE PRODUCTION LINE BEFORE THEY ARE PACKED. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THIS TEST IS REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT210 ADULT BREATHING CIRCUIT "WAS DEFECTIVE AND NOT DELIVERING FLOW TO THE PT. CIRCUIT LOOKED CLEAR OF OBSTRUCTIONS". NO PT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1