BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON PEDIATRIC HEATED-WIRE CIRCUIT

    MDR report key: 2121969 · Received May 24, 2011

    Report

    Report Number
    3004365956-2011-00212
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 11, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    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 CIRCUIT IS CRACKED AT THE PT WYE. THE ALLEGED DEFECT WAS DISCOVERED UPON INSPECTION. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON PEDIATRIC HEATED-WIRE CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02J1002004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA