BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR

    MDR report key: 4563123 · Received March 2, 2015

    Report

    Report Number
    1417411-2015-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    January 12, 2015
    Report Date
    February 2, 2015
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). RECORDS REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT - (B)(4) (SNAP-ON FLOWMETER ADAPTOR) BATCH #4-01422, 5-01421, 5-091422, 6-091421, 6-091422, 7-091421 AND 7-091422 DURING THE MANUFACTURE OF THE MATERIAL. ALTHOUGH THE SAMPLE WAS NOT RETURNED, PREVIOUS COMPLAINTS HAVE BEEN RECEIVED REGARDING THE THREAD ON THE ADAPTOR OF THIS PRODUCT AND A CAPA (B)(4) WAS OPENED TO ADDRESS THE ISSUE. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE HUMIDIFIER ADAPTOR DOES NOT FIT TIGHTLY TO THE OXYGEN FLOW METER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144167 HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR HUMIDIFIER BTT TELEFELX MEDICAL 428147

    Patients

    Seq Age Sex Outcome Treatment
    1