BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1361341 · Received January 14, 2009

    Report

    Report Number
    9611451-2009-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2009
    Date of Event
    December 10, 2008
    Report Date
    December 15, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    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 SOLD IN THE USA. THE 510 (K) FOR THE SIMILAR PRODUCT IS K020332. WE WILL PROVIDE A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THEY COULD NOT CONNECT THE HEATER WIRE ADAPTOR TO AN RT127 INFANT BREATHING CIRCUIT AS THE HEATER WIRE PIN SEEMED TO BE BENT. 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. RT127 080704

    Patients

    Seq Age Sex Outcome Treatment
    1