BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT

    MDR report key: 2171420 · Received June 29, 2011

    Report

    Report Number
    3004365956-2011-00268
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CAP ON THE PORT IS CRACKED. THE ALLEGED DEFECT OCCURRED DURING PRE-TESTING AND PRIOR TO PT USE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02C1102196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA