BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE

    MDR report key: 1860332 · Received September 24, 2010

    Report

    Report Number
    3004365956-2010-00284
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, 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 WAS NOT ABLE TO PASS THE VENTILATOR LEAK TEST. RT NOTICED THE CAP ON THE PORT AT THE WYE MAY BE THE DEFECTIVE COMPONENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE NEONATAL VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02D1002889

    Patients

    Seq Age Sex Outcome Treatment
    1