BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR CIRCUIT, PEDIATRIC, DUAL LIMB

    MDR report key: 2090138 · Received April 11, 2011

    Report

    Report Number
    3004365956-2011-00148
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE COMPLAINT ALLEGES THAT THERE IS AN APPROXIMATE 1/2 INCH SPLIT IN THE CORRUGATED TUBING ON THE INSPIRATORY LIMB OF THE TUBING RIGHT AT THE CONCHA COLUMN OUTLET ADAPTER. THE ALLEGED DEFECT WAS DISCOVERED PRIOR TO PATIENT USE DURING FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON VENTILATOR CIRCUIT, PEDIATRIC, DUAL LIMB VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02F1002766

    Patients

    Seq Age Sex Outcome Treatment
    1