BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT

    MDR report key: 1854030 · Received September 2, 2010

    Report

    Report Number
    3004365956-2010-00252
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 26, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR INVESTIGATION, BUT HAS NOT BEEN RECEIVED AT THIS TIME BY MANUFACTURER. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE ADAPTOR AT THE END OF THE CIRCUIT IS CRACKED. THE DEFECT WAS FOUND BEFORE PT TIME. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02J0802459

    Patients

    Seq Age Sex Outcome Treatment
    1