BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL HEATED-WIRE CIRCUITS

    MDR report key: 2180837 · Received April 28, 2011

    Report

    Report Number
    3004365956-2011-00175
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 4, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS RECEIVED BY MFR, HOWEVER, INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT WOULD NOT PASS THE LEAK TEST. THE CIRCUITS WERE BEING TESTED ON A VENTILATOR WHEN THE ALLEGED DEFECT OCCURRED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL HEATED-WIRE CIRCUITS CIRCUITS BZO TELEFLEX MEDICAL 02J1003592

    Patients

    Seq Age Sex Outcome Treatment
    1