BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG

    MDR report key: 4172818 · Received October 10, 2014

    Report

    Report Number
    3004365956-2014-00371
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    KGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS RECEIVED, HOWEVER, THE EVALUATION WAS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE NEW DESIGN STAR LUMEN TUBING DOESN'T FIT AS TIGHT/FIRMLY AS THE PRIOR SMOOTH BORE MODEL. DURING USE IN A BARIATRIC CHAMBER WHEN THE MASK WAS TUGGED THE LINE CAME OFF. NO PATIENT INJURY. HAD TO STOP THERAPY AND RECONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642954 HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG OXYGEN MASK - NONREBREATHING KGB TELEFLEX 02B1402779

    Patients

    Seq Age Sex Outcome Treatment
    1