BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT

    MDR report key: 1842403 · Received August 31, 2010

    Report

    Report Number
    3004365956-2010-00222
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION, HOWEVER, THE RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE RESPIRATORY SUPERVISOR STATED THAT WHEN SETTING UP THE VENTILATORS FOR THE NICU AND IN DOING THE CIRCUIT PRE-CHECK, SHE HAD MULTIPLE CIRCUITS THAT WOULD NOT PASS THE TEST. THE CIRCUIT WILL NOT STAY CONNECTED TO THE WYE. THE CONNECTION IS TOO LOOSE ON THE EXPIRATORY LIMB. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT VENTILATOR CIRCUIT CAI TELEFLEX MEDICAL NA 02F1002756

    Patients

    Seq Age Sex Outcome Treatment
    1