BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT UNIVERSAL VENTILATOR TUBING SET

    MDR report key: 3013086 · Received March 15, 2013

    Report

    Report Number
    3004365956-2013-00077
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE FOR CATALOG #1619 WAS REVIEWED AND NO FINDINGS WERE FOUND WHICH COULD POTENTIALLY RELATE TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD (DHR) REVIEW 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 SPECS. 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 PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE COMPLAINT ALLEGES THAT THE CIRCUIT LEAKED DURING BIOMED TESTING. THE CIRCUIT WAS NOT USED ON A PT AT THE TIME OF TESTING. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110625 HUDSON ADULT UNIVERSAL VENTILATOR TUBING SET ADULT CONVENTIONAL CIRCUIT BZO TELEFLEX MEDICAL 02A1300807

    Patients

    Seq Age Sex Outcome Treatment
    1