BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE HEATED HUMIDIFIER

    MDR report key: 2241081 · Received August 17, 2011

    Report

    Report Number
    3003898360-2011-00346
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    August 9, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE HEATER WAS BEING USED DURING THE OVERHEATING OF A CIRCUIT. VENTILATOR ALARMS OCCURRED AND THE HEATER HAD TO BE REMOVED FROM THE PT WHEN THE CIRCUIT OVERHEATED. THE CIRCUIT HAD BEEN LAID ACROSS THE PTS ARM AND THE PT SUFFERED A BLISTER-LIKE BURN WITH NO COMPLICATIONS. THE CHIEF OF RESPIRATORY THERAPY STATED THAT HE OBSERVED THE CIRCUIT TO HAVE LEAKS AND HOLES. IT IS UNCERTAIN AT THIS TIME IF THE CIRCUIT WAS A TELEFLEX MEDICAL MANUFACTURED CIRCUIT. ALTHOUGH THE HEATER WAS NOT IMPLICATED DIRECTLY; THE HOSPITAL IS RETURNING THE HEATER TO BE TESTED. PT WAS DISCHARGED FROM THE HOSPITAL AND DOING FINE. ADDITIONAL INFORMATION AND CLARIFICATION REQUESTED REGARDING THE COMPLAINT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CONCHA NEPTUNE HEATED HUMIDIFIER HEATED HUMIDIFIER BTT TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK