BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR

    MDR report key: 4791396 · Received May 21, 2015

    Report

    Report Number
    3004365956-2015-00151
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO ISSUES WERE OBSERVED. THE RECEIVED SAMPLE WAS CONNECTED TO A CONCHA NEPTUNE AND IT WAS TESTED FOR ONE HOUR IN ORDER TO CONFIRM THE FAILURE MODE REPORTED BY THE CUSTOMER; HOWEVER, NO ISSUES WERE FOUND. THE CIRCUIT REMAINED CONNECTED TO THE COLUMN AND DID NOT "POP OFF" AS REPORTED IN THE COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO ISSUES WERE FOUND WITH THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4), A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT REC'D YET AT OUR FACILITY. THE DEVICE HISTORY RECORD OF BATCH NUMBER (B)(4) THAT BELONG TO CATALOG NUMBER 2416 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWED THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECS. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS TIME WITHOUT THE DEVICE SAMPLE OR PICTURE AVAILABLE FOR EVAL. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING A HEATER TRIAL, THE CIRCUIT POPPED OFF OF THE COLUMN AND THE PATIENT'S OXYGEN LEVEL DROPPED HOWEVER; THERE WERE NO REPORTS OF PATIENT INJURY OR HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT DURING A HEATER TRIAL, THE CIRCUIT POPPED OFF OF THE COLUMN AND THE PATIENT'S OXYGEN LEVEL DROPPED, HOWEVER; THERE WERE NO REPORTS OF PATIENT INJURY OR HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331692 HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR CANNULA HUMIDIFICTION SYSTEM BTT TELEFLEX MEDICAL 74L1403294

    Patients

    Seq Age Sex Outcome Treatment
    1