BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULMO-MIST AEROSOL COMPRESSOR

    MDR report key: 3281156 · Received August 2, 2013

    Report

    Report Number
    1039215-2013-00003
    Event Type
    Other
    Date Received
    August 2, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 23, 2013
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAF
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL E-MAIL COMMUNICATION WAS TO REQUEST A COPY OF THE USER'S MANUAL. IN A SUBSEQUENT TELEPHONE COMMUNICATION, IT WAS STATED THAT THE "NEBULIZER FELL IN BED WITH A PATIENT". CUSTOMER REPORT STATES: "NURSE PLACED THE NEBULIZER ON THE PATIENT'S BED DURING HER TREATMENT". THE USER'S MANUAL CLEARLY STATES: "THIS PRODUCT SHOULD NEVER BE LEFT UNATTENDED WHEN PLUGGED IN. CLOSE SUPERVISION IS NECESSARY WHEN THIS PRODUCT IS USED BY, ON OR NEAR CHILDREN AND PHYSICALLY IMPAIRED INDIVIDUALS" AND "NEVER BLOCK THE AIR OPENINGS OF THE PRODUCT OR PLACE IT ON A SOFT SURFACE, SUCH AS A BED OR COUCH WHERE THE AIR OPENINGS MAY BE BLOCKED."

    Description of Event or Problem · 1

    NURSE PLACED THE NEBULIZER ON THE PATIENT'S BED DURING HER TREATMENT. THE PATIENT HAS PARAPLEGIA AND WAS UNABLE TO FEEL THE UNIT GETTING HOT. A CNA WENT TO THE ROOM AND FOUND THAT THE UNIT WAS QUITE HOT AND HAD CAUSED A SMALL BURN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364247 PULMO-MIST AEROSOL COMPRESSOR NEBULIZER CAF NIDEK MEDICAL PRODUCTS, INC. 4323

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other