BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW W/040 ADAPTOR

    MDR report key: 2033593 · Received February 10, 2011

    Report

    Report Number
    1417411-2011-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 19, 2011
    Manufacturer
    TELEFELX 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

    THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION. THE RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AIR LEAKS THROUGH THE ADAPTOR. IT WAS UNSTABLE WHEN SET WITH THE FLOWMETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK 340 SW W/040 ADAPTOR AQUAPAK HUMIDIFIER CAF TELEFELX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK