BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAPKAK W/ADAPTOR

    MDR report key: 1942050 · Received November 9, 2010

    Report

    Report Number
    1417411-2010-00048
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 20, 2010
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. AT THE TIME OF THIS REPORT THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AN AIR LEAK WAS FOUND AT THE ADAPTOR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAPKAK W/ADAPTOR BUBBLE HUMIDIFIER BTT TELEFELX MEDICAL NA 173107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK