BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR TUBING SET, NOVATION

    MDR report key: 3131250 · Received May 23, 2013

    Report

    Report Number
    3004365956-2013-00187
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE PRODUCT WAS NOT RETURNED. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE FOR CATALOG #1613V WERE REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE REPORTED LOT NUMBER THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF THE PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE COMPLAINT ALLEGES THAT HOLES WERE FOUND IN THE CIRCUIT. THE CIRCUIT FAILED TESTING ON A DRAGER XL VENTILATOR PRIOR TO PATIENT USE. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230088 HUDSON VENTILATOR TUBING SET, NOVATION ADULT CONVENTIONAL VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL 02K1202475

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAGER XL VENTILATOR