BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1695655 · Received May 17, 2010

    Report

    Report Number
    9611451-2010-00281
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Report Date
    April 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS 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. WE ARE CURRENTLY SEEKING FURTHER INFORMATION REGARDING THIS EVENT. WE WILL PROVIDE A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS EXCESS CONDENSATION IN AN RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUIT. THIS WAS NOTICED PRIOR TO PATIENT CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT212

    Patients

    Seq Age Sex Outcome Treatment
    1