BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPA LIGHT WITH PORT

    MDR report key: 2201320 · Received August 3, 2011

    Report

    Report Number
    8040412-2011-00114
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE BREATHING MACHINE ALARMED DURING CONNECTION TO HUMIDIFICATION & FILTRATION ON A PATIENT. AFTER THE NURSE CHECKED AND DISCOVERED THAT THE HUMIDIFICATION & FILTRATION WAS LEAKING DUE TO A MONITORING CAP THAT WAS BROKEN AND FELL INTO THE FILTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPA LIGHT WITH PORT LIGHT WITH PORT BTT TELEFLEX MEDICAL NA 201104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK