BEUDAMED
    FDA Adverse Event Summary report: N

    NEBULIZERS TO DELIVER AEROSOLS

    MDR report key: 2575587 · Received May 16, 2012

    Report

    Report Number
    1531186-2012-00263
    Date Received
    May 16, 2012
    Report Date
    May 14, 2012
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER STATED THAT THE NEBULIZER GOT VERY HOT AND SMELLED LIKE IT WAS BURNING AND THE MEDICINE WOULD NOT FLOW OUT. THIS DEVICE IS A PEDIATRIC BEAR NEBULIZER FOR A CHILD. THE USES AGE, HEIGHT AND WEIGHT ARE UNKNOWN. PAGE 9 OF THE OWNER'S MANUAL STATES A WARNING, "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 THE LIKE. BLOCKED OPENINGS MAY CAUSE THE UNIT TO SHUT DOWN. CONTACT DEALER IMMEDIATELY. THE COMPRESSOR NEBULIZER SYSTEM USES THE SURROUNDING AIR TO EFFECTIVELY ADMINISTER THE PRESCRIBED MEDICATION THROUGH THE NEBULIZER. THE USER AND ADMINISTRATOR SHOULD BE AWARE OF SURROUNDINGS SO AS NOT TO HAVE CONTAMINATED AIR FILTERED THROUGH THE COMPRESSOR NEBULIZER SYSTEM. (EXAMPLES CAN BE AIR CONTAMINATED WITH PAINT OR CLEANING FUMES, WEED KILLER,CAR EXHAUST, ETC.) DO NOT USE THE COMPRESSOR NEBULIZER SYSTEM IN THESE ENVIRONMENTS. OTHERWISE, SERIOUS BODILY INJURY MAY OCCUR". INVACARE PROVIDED THE CONSUMER WITH A LIST OF SERVICE CENTERS IN HER AREA. NO RMA HAS BEEN ISSUED AT THIS TIME FOR THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES NEBULIZER GOT VERY HOT, SMELLED LIKE IT WAS BURNING AND MEDICINE WOULD NOT COME OUT. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZERS TO DELIVER AEROSOLS 868.5630 CAF EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other