BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1203446 · Received October 17, 2008

    Report

    Report Number
    9611451-2008-00599
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 17, 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

    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. THE DEVICE IS EN ROUTE TO THE MFR FOR INSPECTION. WE WILL PROVIDE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A HOSP IN ANOTHER COUNTRY, REPORTED VIA OUR DISTRIBUTOR THAT A LOW HUMIDITY ALARM OCCURRED ON AN RT226 INFANT BREATHING CIRCUIT AFTER IT HAD BEEN USED FOR 4 DAYS. IT WAS ALSO REPORTED THE HEATERWIRE WAS UNHOOKED. 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. RT226

    Patients

    Seq Age Sex Outcome Treatment
    1