BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1220365 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00640
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 3, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. WE ARE CURRENTLY INVESTIGATION THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED VIA OUR DISTRIBUTOR THAT THE ROD IN THE WATER TRAP OF AN RT225 INFANT BREATHING CIRCUIT WAS BENT. THEY REPORTED THAT THEY WERE UNABLE TO ASSEMBLE THE DEVICE AND THAT WHEN THEY TRIED TO FORCE THE ROD BACK INTO THE APPROPRIATE POSITION, IT BROKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 060619

    Patients

    Seq Age Sex Outcome Treatment
    1