BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB PRO COMPRESSOR

    MDR report key: 3000073 · Received March 8, 2013

    Report

    Report Number
    1044475-2013-00028
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE UNIT HAS A VERY LOW FLOW OUTPUT. THE ALLEGED FAILURE OCCURRED DURING PATIENT USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98921 HUDSON OPTI-NEB PRO COMPRESSOR NEBULIZER COMPRESSOR CAF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1