BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 1222839 · Received November 6, 2008

    Report

    Report Number
    9611451-2008-00657
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 3, 2008
    Manufacturer
    FISHER * PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS DUE TO BE INVESTIGATED. WE WILL PROVIDE A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN A FOREIGN COUNTRY, REPORTED THAT AN RT236 INFANT BREATHING CIRCUIT WAS CAUSING ALARMS CONSTANTLY. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BZE FISHER * PAYKEL HEALTHCARE LTD RT236 080704

    Patients

    Seq Age Sex Outcome Treatment
    1