BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NOVATION VENTILATOR TUBING SET, LONG

    MDR report key: 3063590 · Received April 12, 2013

    Report

    Report Number
    3004365956-2013-00118
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD OF LOT NUMBER 02K1202475 HAS BEEN REVIEWED AND THERE WERE NO ISSUES OR DISCREPANCIES FOUND WHICH COULD POTENTIALLY RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE DEVICE WOULD NOT PASS THE LEAK TEST. THE REPORTED ISSUE WAS DETECTED PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158037 HUDSON NOVATION VENTILATOR TUBING SET, LONG VENTILATOR TUBING SET BZO TELEFLEX 02K1202475

    Patients

    Seq Age Sex Outcome Treatment
    1