BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL DUAL LIMB HEATED WIRE CIRCUIT

    MDR report key: 1221521 · Received November 5, 2008

    Report

    Report Number
    3004365956-2008-00064
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Report Date
    October 10, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES REQUESTED, BUT NOT RECEIVED. INVESTIGATION REPORT IS NOT YET AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT IT WAS DISCOVERED IN THE SUPPLY ROOM THAT THE CIRCUIT WAS FOUND TO BE FALLING APART. IT WAS NOT USED ON A PATIENT. NO CLINICAL CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEONATAL DUAL LIMB HEATED WIRE CIRCUIT DUAL LIMB BREATHING CIRCUIT BZO TELEFLEX MEDICAL 02294

    Patients

    Seq Age Sex Outcome Treatment
    1