BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT HEATED-WIRE

    MDR report key: 1842703 · Received August 27, 2010

    Report

    Report Number
    3004365956-2010-00247
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR FOR EVAL, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CAP THAT OCCLUDES THE PRESSURE LINE PORT IS CRACKED AND WILL NOT PASS VENTILATOR LEAK TEST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT HEATED-WIRE VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02A1002480

    Patients

    Seq Age Sex Outcome Treatment
    1