BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK HUMIDIFIER 340 ML W/ADAPTOR

    MDR report key: 2901471 · Received January 3, 2013

    Report

    Report Number
    1417411-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 10, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE FOUND TO BE WITHIN SPECIFICATION AND ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. THE SAMPLE WAS NOT RETURNED FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: AN OXYGEN LEAK WAS DETECTED DURING USE. IT IS REPORTED THAT THE PT BECAME CYANOTIC. THE PT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229 HUDSON AQUAPAK HUMIDIFIER 340 ML W/ADAPTOR AQUAPAK HUMIDIFIER BTR TELEFLEX 274127

    Patients

    Seq Age Sex Outcome Treatment
    1