BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL HEATED-WIRE CIRCUIT

    MDR report key: 1915424 · Received November 5, 2010

    Report

    Report Number
    3004365956-2010-00325
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE AND RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING PRE-TESTING OF THE CIRCUITS, IT WAS NOTED THAT THERE WAS A LEAK IN THE AREA OF THE CAP. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL HEATED-WIRE CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02C1003697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA