BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUA 540 SW, 540 W/040 ADAPTOR

    MDR report key: 2211143 · Received August 8, 2011

    Report

    Report Number
    1417411-2011-00080
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 27, 2011
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT AIR IS LEAKING FROM THE ADAPTER DURING USE. COMPLAINT ALLEGES THAT THE WATER IS NOT BUBBLING AND IT DOESN'T APPEAR TO BE A GOOD SEAL. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUA 540 SW, 540 W/040 ADAPTOR NEBULIZER ADAPTOR CAF TELEFELX MEDICAL NA 016115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA