BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK WITH ADAPTOR

    MDR report key: 1765863 · Received July 7, 2010

    Report

    Report Number
    1417411-2010-00024
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 15, 2010
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    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 NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE SWAN NECK NOZZLE WAS ALMOST OCCLUDED SO THAT THE BOTTLE BECAME OVER INFLATED WITH THE FLOW RATE OF 8-10L/M. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK WITH ADAPTOR AQUAPAK BUBBLE HUMIDIFIER BTT TELEFELX MEDICAL NA 072196

    Patients

    Seq Age Sex Outcome Treatment
    1