BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT PARALLEL CONCHA COLUMN

    MDR report key: 2211155 · Received August 8, 2011

    Report

    Report Number
    1417411-2011-00083
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 28, 2011
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE COLUMN FAILED THE LEAK TEST ON THE DRAGGER VENTILATOR. COMPLAINT ALLEGES THAT WHEN THE COLUMN WAS BYPASSED, THERE WAS NO LEAK. NEW COLUMNS WERE INSERTED AND THE VENTILATORS PASSED THE LEAK TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT PARALLEL CONCHA COLUMN CONCHA COLUMN BTT TELEFELX MEDICAL NA 02M1002358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA