BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK HUMIDIFIER ADAPTOR

    MDR report key: 2002285 · Received January 26, 2011

    Report

    Report Number
    1417411-2011-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER FOR EVALUATION BUT THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE YELLOW WING NUT ON TOP OF THE ADAPTOR LEAKS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK HUMIDIFIER ADAPTOR AQUAPAK ADAPTOR CAF TELEFLEX MEDICAL NA YF17

    Patients

    Seq Age Sex Outcome Treatment
    1