BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT 18" 21 V

    MDR report key: 2172633 · Received June 23, 2011

    Report

    Report Number
    3004365956-2011-00263
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 CIRCUIT WOULD NOT PASS THE LEAK TEST ON THE VENTILATOR. ALLEGED INCIDENT OCCURRED PRIOR TO PT USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HEATED-WIRE VENTILATOR CIRCUIT 18" 21 V VENTILATOR CIRCUIT BTT TELEFLEX MEDICAL NA 02A1100166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA