BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL HEATED WIRE VENTILATOR CIRCUIT

    MDR report key: 2052004 · Received February 28, 2011

    Report

    Report Number
    3004365956-2011-00083
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT HAS A TEAR IN THE CAP THAT COVERS THE PRESSURE PORT ON THE WYE OF THE CIRCUIT. THE ALLEGED DEFECT WAS DISCOVERED DURING A PRE-USE CHECK ON A SERVO I VENTILATOR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL HEATED WIRE VENTILATOR CIRCUIT NEONATAL VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1