BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT, HEATED-WIRE

    MDR report key: 1860409 · Received September 27, 2010

    Report

    Report Number
    3004365956-2010-00266
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR FOR EVAL, HOWEVER, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT WILL NOT PASS THE 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 02E1001100

    Patients

    Seq Age Sex Outcome Treatment
    1