BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT VENTILATOR CIRCUIT

    MDR report key: 2934861 · Received January 23, 2013

    Report

    Report Number
    3004365956-2013-00033
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT COMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE INSPIRATORY LIMB OF THE CIRCUIT DETACHED FROM THE COLUMN ONCE THE CIRCUIT HAD PRESSURE APPLIED TO IT. THIS ISSUE WAS DISCOVERED DURING THE LEAK TESTING PRIOR TO PT USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32979 HUDSON ADULT VENTILATOR CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NEPTUNE HEATER| COVIDIAN 840 VENTILATOR