BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON PEDIATRIC VENTILATOR CIRCUIT

    MDR report key: 2062450 · Received March 18, 2011

    Report

    Report Number
    3004365956-2011-00114
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, 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: CIRCUIT HAS CRACKS IN THE ADAPTOR WHERE THE TEMPERATURE PROBE CONNECTS AT THE PT END. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON PEDIATRIC VENTILATOR CIRCUIT PEDIATRIC VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02F1000305

    Patients

    Seq Age Sex Outcome Treatment
    1