BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE

    MDR report key: 3813230 · Received March 31, 2014

    Report

    Report Number
    1044475-2014-00103
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 19, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE UNIT POWER CORD IS FRAYED AND EXPOSING ELECTRICAL POWER WIRES. THE ALLEGED ISSUE WAS DISCOVERED PRIOR TO USE. NO PATIENT INJURY/INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189872 HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE NEBULIZER COMPRESSOR CAF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1