BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON 780-15 CIRCUIT W/ COLUMN

    MDR report key: 5996511 · Received October 4, 2016

    Report

    Report Number
    3004365956-2016-00356
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE DOCTOR, FROM THE USER FACILITY , THE PATIENT'S DEATH WAS NOT DUE TO THE ALLEGED ISSUE WITH THE DEVICE AND DID NOT CHANGE THE PATIENT'S OUTCOME. A VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION OF THE DEVICE COULD NOT BE CONDUCTED SINCE THE DEVICE SAMPLE WAS DISCARDED BY THE USER FACILITY. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER 74F1600958 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 SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CIRCUIT PASSED THE VENT TEST BEFORE PLACEMENT ON THE PATIENT. THE CIRCUIT DEVELOPED LEAK(S) AFTER THE DEVICE WAS IN USE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650249 HUDSON 780-15 CIRCUIT W/ COLUMN HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 74F1600958

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO SERVO 1 VENTILATOR