BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT BREATHING CIRCUIT

    MDR report key: 2833867 · Received November 5, 2012

    Report

    Report Number
    3004365956-2012-00315
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE DHR (DEVICE HISTORY RECORD) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR ALSO SHOWED THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CIRCUIT FAILED THE LEAK PRE-TEST. TEST WAS CONDUCTED PRIOR TO PT USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT BREATHING CIRCUIT VENTILATOR CIRCUIT CBK TELEFLEX MEDICAL 02H1202312

    Patients

    Seq Age Sex Outcome Treatment
    1