BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR

    MDR report key: 3061338 · Received April 10, 2013

    Report

    Report Number
    3003898360-2013-00160
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPLAINT ALLEGES THAT THE COLUMN DID NOT PASS THE LEAK TEST. THIS OCCURRED PRIOR TO USE ON A PT. NO PT INJURY/INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148862 HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR HEATED HUMIDIFICATION SYSTEM BTT TELEFLEX MEDICAL 02G11

    Patients

    Seq Age Sex Outcome Treatment
    1