BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB PRO NEBULIZER COMPRESSOR

    MDR report key: 2172266 · Received June 23, 2011

    Report

    Report Number
    1044475-2011-00072
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Report Date
    June 15, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT AT THE COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE TUBING GETS HOT WHEN BEING USED WITH THE COMPRESSOR TO ADMINISTER TREATMENTS. COMPLAINT INDICATES THAT THE UNIT HAS TO BE RANDOMLY CUT OFF AND ON IN ORDER TO COOL THE UNIT DOWN TO BE ABLE TO CONTINUOUSLY ADMINISTER TREATMENTS. NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK