BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT HEATED WIRE CIRCUIT

    MDR report key: 1881985 · Received October 12, 2010

    Report

    Report Number
    3004365956-2010-00308
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: DEVICE HISTORY RECORD (DHR) REVIEW, PROCESS REVIEW. RESULTS: DHR REVIEW SHOWED NO DISCREPANCIES POTENTIALLY RELATED TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECS. REVIEW OF THE ASSEMBLY PROCESS AND MFG PROCEDURE FOR CATALOG #780-36 SHOWED NO ISSUES THAT POTENTIALLY RELATES TO THE REPORTED ISSUE. CONCLUSIONS: CAPA (B)(4) WAS OPENED TO DOCUMENT THE ROOT CAUSE AND CORRECTIVE ACTIONS TO REDUCE LEAKS AND DISCONNECTIONS OF CIRCUITS. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING SET-UP, THE CIRCUIT HAD A LEAK. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT HEATED WIRE CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02C1000266

    Patients

    Seq Age Sex Outcome Treatment
    1