BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED

    MDR report key: 1812491 · Received August 16, 2010

    Report

    Report Number
    3004365956-2010-00190
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CIRCUIT WILL NOT PASS LEAK TEST. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02D1001083

    Patients

    Seq Age Sex Outcome Treatment
    1