BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NE-C21 COMP AIR ELITE NEBULIZER SYSTEM

    MDR report key: 1893280 · Received October 28, 2010

    Report

    Report Number
    1450057-2010-00003
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    January 22, 2008
    Report Date
    October 26, 2010
    Manufacturer
    OMRON MATSUSAKA CO., LTD.
    Product Code
    CAF
    PMA / PMN Number
    K914836/B
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS FOUND DURING A RETROSPECTION LOOK BACK (CAPA (B)(4)) OF ELEVATED COMPLAINTS. THIS IS AN INITIAL AND FINAL REPORT. LIMITED INFO IS AVAILABLE REGARDING THE RETURNED UNIT. SERIAL/LOT NUMBER INFO IS NOT AVAILABLE BECAUSE IT WAS WORN OFF THE UNIT. THE UNIT WAS RECEIVED BY THE IMPORTER/DISTRIBUTOR AND REPLACED WITH A COMPARABLE NEW UNIT DUE TO IT'S DISCONTINUED STATUS AND THE WARRANTY. THE UNIT IS NO LONGER IN RETENTION. A VISUAL INSPECTION WAS PERFORMED BY THE REPAIR DEPT AND DETERMINED THE CLIPS ON THE COMPONENT MEDICINE CUP WERE BROKEN. IF THE MEDICINE CUP IS NOT ALIGNED AND SEATED CORRECTLY OR FORCIBLY TWISTED ONTO THE BASE OF THE UNIT, THE SIDE "CLIPS" WILL BREAK OFF.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS WHILE DRIVING HOME FROM WORK SHE HAD A RESPIRATORY ATTACK. CUSTOMER CLAIMS THE "POINTS" (CLIPS) ON THE MEDICINE CUP BROKE AND SHE COULD NOT ADEQUATELY NEBULIZE. CUSTOMER CLAIMS SHE CALLED AN EMT SERVICE AND WAS ADMITTED TO THE HOSPITAL IN RESPIRATORY ARREST AND PUT ON A VENTILATOR. CUSTOMER CLAIMS SHE WAS ILL, OFF WORK AND UNDER MEDICAL CARE DUE TO THE DEVICE FAILURE. CUSTOMER CLAIMS SHE CLEANS HER DEVICE DAILY USING WATER ONLY; BEING CAREFUL NOT TO DAMAGE THE FILTERS OR OTHER PARTS. STATED SHE IS A LONG TIME USER OF RESPIRATORY DEVICES AND FEELS SHE DID NOT BREAK OR DAMAGE THE UNIT. CUSTOMER CLAIMS PROD HAS A DESIGN FLAW. RETURNING UNIT FOR INSPECTION VIA A CALL TAG. MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NE-C21 COMP AIR ELITE NEBULIZER SYSTEM COMPRESSOR NEBULIZER CAF OMRON MATSUSAKA CO., LTD. NE-C21 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization