BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HCH, AQUA+

    MDR report key: 1935428 · Received November 10, 2010

    Report

    Report Number
    8040412-2010-00084
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 25, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK, AT THE TIME OF THIS REPORT, IF THE DEVICE SAMPLE IS AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE WAS A PT ISSUE OF DECREASED VENTILATION WHILE ON THE HME (B)(4). THE PT DID NOT EXPERIENCE A DE-SATURATION OF OXYGEN. THE PT WAS ON A VENTILATOR WHILE USING THE HUDSON (B)(4) ADULT CIRCUIT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HCH, AQUA+ HME FILTER BTT TELEFLEX MEDICAL NA 201024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK