BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB COMPRESSOR

    MDR report key: 2152518 · Received June 21, 2011

    Report

    Report Number
    1044475-2011-00073
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 13, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE UNIT IS NOT PRODUCING ENOUGH PRESSURE TO NEBULIZE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON OPTI-NEB COMPRESSOR NEBULIZER COMPRESSOR CAF TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK