BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUDSON CONCHATHERM NEPTUNE

    MDR report key: 1714583 · Received June 9, 2010

    Report

    Report Number
    3003898360-2010-00236
    Event Type
    Other
    Date Received
    June 9, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 12, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT - OTHER - THE WATER TUBING WAS CLAMPED OFF AND PATIENT DID NOT RECEIVE HUMIDIFICATION FOR 14 HOURS. THE PATIENT (B)(6) REQUIRED EXTENSIVE SUCTIONING AND LAVAGE. EVALUATION, METHOD: OTHER - HISTORICAL INFORMATION REVIEW. RESULTS: OTHER - HISTORICAL INFORMATION REVIEW FROM (B)(6) 2009 TO (B)(6) 2010 SHOWED NO SIMILAR COMPLAINTS FOR THIS MATERIAL NUMBER. NO DEVICE SAMPLE AVAILABLE FOR EVALUATION. NO LOT NUMBER PROVIDED. ROOT CAUSE - CUSTOMER MISUSE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHILE INSERTING A NEW WATER BOTTLE, THE WATER TUBING WAS CLAMPED OFF AND THIS TUBING WAS NOT UN-CLAMPED. THE PATIENT (B)(6) WENT WITHOUT HUMIDITY FOR 14 HOURS. THE PATIENT DECOMPENSATED GOING FROM THE BABYLOG VENTILATOR TO OSCILLATOR SUPPORT AND INCREASED FI02. THIS PATIENT ALSO REQUIRED EXTENSIVE SUCTIONING AND LAVAGE. THE CUSTOMER REPORTS THAT THE THERAPIST DID NOT NOTICE THE CLAMPED TUBING UNTIL A LATER TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention