BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT HEATED WIRE CIRCUIT KIT

    MDR report key: 2844672 · Received November 9, 2012

    Report

    Report Number
    3004365956-2012-00320
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Report Date
    October 26, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE PRESSURE LINE CONTINUES TO POP OFF, BREAKING THE CIRCUIT AND SETTING ALARMS OFF. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT HEATED WIRE CIRCUIT KIT VENTILATOR CIRCUIT CBK TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1