BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT, DUALLIMB

    MDR report key: 2043055 · Received February 23, 2011

    Report

    Report Number
    3004365956-2011-00072
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT FAILED THE LEAK TEST PRIOR TO PT USE. IT WAS NOTICED THAT THE BLUE CORRUGATED TUBING IS SPLITTING AT THE SEAM AT THE WHITE CONNECTOR. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HEATED-WIRE VENTILATOR CIRCUIT, DUALLIMB VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02J1002004

    Patients

    Seq Age Sex Outcome Treatment
    1