BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON STERILE WATER AQUAPAK HUMIDIFIER 650 ML

    MDR report key: 1915480 · Received November 5, 2010

    Report

    Report Number
    1417411-2010-00049
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, 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: THERE IS A PINHOLE JUST BELOW THE SWAN NECK. IT WAS FOUND BEFORE USE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON STERILE WATER AQUAPAK HUMIDIFIER 650 ML AQUAPAK HUMIDIFIER CAF TELEFLEX MEDICAL NA 034106

    Patients

    Seq Age Sex Outcome Treatment
    1