BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON DUAL-LIMB CIRCUIT, PEDIATRIC

    MDR report key: 2013807 · Received February 3, 2011

    Report

    Report Number
    3004365956-2011-00045
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT FAILED THE PRESSURE TEST UPON SET-UP. THERE WAS A VISIBLE SPLIT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON DUAL-LIMB CIRCUIT, PEDIATRIC VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA