BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW W/040 ADAPTOR, FREN

    MDR report key: 3000071 · Received March 8, 2013

    Report

    Report Number
    1417411-2013-00007
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT AS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO SAMPLE RETURNED FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE - UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMER ON ISSUES RELATED TO NO OXYGEN GOING TO A PATIENT DURING USE OF WATER BOTTLE PRODUCTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AFTER CONNECTING THE ADAPTOR TO THE FLOW METER, THE NURSE NOTICED THAT THE OXYGEN WENT TO THE AQUAPAK BUT NOTHING WENT TO THE PATIENT. THE BOTTLE INFLATED AND EMITTED A WHISTLE. THE DEVICE WAS REMOVED. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98917 HUDSON AQUAPAK 340 SW W/040 ADAPTOR, FREN BUBBLE HUMIDIFIER BTR TELEFELX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1