BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK WITH ADAPTOR

    MDR report key: 1842358 · Received August 30, 2010

    Report

    Report Number
    1417411-2010-00030
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 18, 2010
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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: THE PT WAS RECEIVING OXYGEN AT A HIGH FLOW RATE OF 8L/MIN. THE PT COMPLAINED OF NOT FEELING AS WELL AS THE DAY BEFORE. THE PT'S OXYGEN SATURATION DROPPED TO 82%, WHEREAS THE DAY BEFORE IT WAS AROUND 97%. THE DEVICE AND CONNECTIONS WERE CHECKED AND IT LOOKED AS IF THERE WAS A LEAK AT THE LEVEL OF THE FOLD IN THE PLASTIC. THE AQUAPAK WAS SUCCESSFULLY CHANGED AND THE PT'S OXYGEN SATURATION INCREASED TO 96%. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1