BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT HEATED-WIRE CIRCUIT

    MDR report key: 1872251 · Received October 12, 2010

    Report

    Report Number
    3004365956-2010-00306
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD - DEVICE HISTORY RECORD (DHR) REVIEW. RESULTS: THE DHR WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE REPORTED LOT THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECS. CONCLUSIONS: CAPA (B)(4) WAS OPEN IN ORDER TO DOCUMENT THE ROOT CAUSE AND CORRECTIVE ACTION FOR THIS ISSUE. CAPA (B)(4) WAS ISSUED FOR R&D TO DOCUMENT THE CHANGES TO REDUCE LEAKS AND DISCONNECTIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT FAILED THE LEAK TEST. THE PRODUCT WAS VERY LOOSE AT THE LOCATION WHERE THE EXHALATION TUBING CONNECTS TO THE PB EXHALATION FILTER. THE REPORTED ISSUE WAS FOUND PRIOR TO PT USE AND DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ADULT HEATED-WIRE CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02G0900151

    Patients

    Seq Age Sex Outcome Treatment
    1