BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL VENTILATOR CIRCUIT W/18 IN R

    MDR report key: 2160213 · Received June 2, 2011

    Report

    Report Number
    3004365956-2011-00225
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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 DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CIRCUITS WERE FOUND TO HAVE PROXIMAL PORT CAP CRACK. THE ALLEGED DEFECT WAS DISCOVERED DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL VENTILATOR CIRCUIT W/18 IN R VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02A1101919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA