BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE

    MDR report key: 1883112 · Received October 18, 2010

    Report

    Report Number
    3004365956-2010-00310
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, BUT INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE INFANT CIRCUIT WILL NOT PASS THE LEAK TEST. THE EXPIRATORY LIMB CAN BE EASILY REMOVED FROM THE CAGED CUFF CONNECTOR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02F1000308

    Patients

    Seq Age Sex Outcome Treatment
    1