BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT VENTILATOR TUBING/CIRCUIT

    MDR report key: 3127302 · Received May 20, 2013

    Report

    Report Number
    3004365956-2013-00180
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER (02K1201913) 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. FOR CAT # 1619 THE ASSEMBLY PROCESS AND MFG PROCEDURE WERE REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF THE PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. THE COMPONENT INVOLVED P/N MP-0498 IS A MOLDING COMPONENT. ALTHOUGH THE CUSTOMER COMPLAINT WAS NOT CONFIRMED, BASED ON SIMILAR COMPLAINTS, THE MOLDING DEPT IS GOING TO IMPROVE THE PROCESS (PARAMETERS SHEET) IN ORDER TO ASSURE GOOD RETENTION BETWEEN THE PLUG AND TEMP PROBE PORT.

    Description of Event or Problem · 1

    THE COMPLAINT REPORTED AS: THE CUSTOMER ALLEGES THAT THE TEMP PROBE CAP, ON THE CIRCUIT, WILL NOT STAY CLOSED WHEN VENTILATING. THIS ISSUE DETECTED PRIOR TO PT USE DURING FUNCTIONAL TESTING/INSPECTION. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223352 HUDSON ADULT VENTILATOR TUBING/CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL 02K1201913

    Patients

    Seq Age Sex Outcome Treatment
    1