BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCHA NEPTUNE HEATER

    MDR report key: 2011799 · Received February 22, 2011

    Report

    Report Number
    3003898360-2011-00056
    Event Type
    Other
    Date Received
    February 22, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR SERIAL NUMBER HAVE BEEN RECEIVED BY MANUFACTURER FOR EVAL. THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE ET TUBE PLUGGED DUE TO LACK OF HUMIDITY FROM THE HEATER AND THE PT WENT INTO CARDIAC ARREST. COMPLAINT INDICATES THAT THE PT WAS RECEIVING MECHANICAL VENTILATION WHEN THE ALLEGED INCIDENT OCCURRED. RESUSCITATION HAD TO BE ADMINISTERED AND THE PT HAD TO BE REINTUBATED. CONDITION OF PT IS UNAVAILABLE AT THIS TIME. ADDITIONAL INFO REQUESTED BUT NOT RECEIVED IN TIME FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCHA NEPTUNE HEATER HEATER BZE TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention