BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEB100

    MDR report key: 8286974 · Received January 29, 2019

    Report

    Report Number
    3006446479-2019-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Manufacturer
    SUNSET HEALTHCARE SOLUTIONS
    Product Code
    CAF
    UDI-DI
    00848530087326
    PMA / PMN Number
    K091272
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUNSET COMPRESSOR NEBULIZER, NEB100, CLEARED FOR USE IN THE U.S. [510(K) K091272], WAS SOLD BY A THIRD-PARTY DISTRIBUTOR IN (B)(4) WHERE THE VOLTAGE IS 220V. THIS DEVICE NEB100 DEVICE IS DESIGNED FOR THE U.S. MARKET, WITH A VOLTAGE REQUIREMENT OF 120V. WHEN THE DEVICE WAS USED OUTSIDE OF ITS SPECIFIED VOLTAGE, THE MOTOR OVERHEATED AND STOPPED FUNCTIONING. THERE WERE NO REPORTS OF ANY DEATH OR INJURY ASSOCIATED WITH THE OVERHEATING. THE DISTRIBUTOR IN (B)(4) HAS RECALLED THE DEVICE IN THAT MARKET AND TAKEN REMEDIAL ACTION TO PREVENT RISK OF RECURRENCE. THE DISTRIBUTOR HAS RECOVERED ALL SOLD DEVICES AND DISPOSED OF THEM IN COMPLIANCE WITH LOCAL REGULATIONS. THE INVESTIGATION BY SUNSET HEALTHCARE SOLUTIONS SUPPORTS THAT THE INCIDENTS WERE CAUSED SOLELY BY A USE ERROR. THE DEVICE MALFUNCTIONED DUE TO THE IMPROPER VOLTAGE USED TO RUN THE DEVICE. THE NEB100 DEVICE INSTRUCTION MANUAL UNDER THE CAUTION SECTION PROVIDE CLEAR INSTRUCTIONS TO ENSURE THE ELECTRICAL RATING FOR THE DEVICE (I.E., 120V) CORRESPONDS TO THE USER'S MAIN VOLTAGE AND FREQUENCY BEFORE PLUGGING IN THE DEVICE. ADDITIONALLY, THE ELECTRICAL RATING OF 120V IS CLEARLY MARKED ON THE BOTTOM PLATE OF THE UNIT. THE INSTRUCTION MANUAL ALSO CAUTIONS AGAINST USING ELECTRICAL ADAPTERS INCLUDING EXTENSION CORDS. AS THIS NEB100 PRODUCT IS SOLELY MANUFACTURED AND MARKETED FOR THE U.S. MARKET, WHICH UTILIZES THE 120V ELECTRICAL RATING, IT WAS DETERMINED THAT. THERE IS A REMOTE POSSIBILITY THIS MALFUNCTION WOULD OCCUR WHILE IN THE U.S.

    Description of Event or Problem · 1

    THE SUNSET COMPRESSOR NEBULIZER, NEB100, CLEARED FOR USE IN THE U.S. WAS SOLD BY A THIRD-PARTY DISTRIBUTOR IN (B)(4) WHERE THE VOLTAGE IS 220V. THIS DEVICE NEB100 DEVICE IS DESIGNED FOR THE U.S. MARKET, WITH A VOLTAGE REQUIREMENT OF 120V. WHEN THE DEVICE WAS USED OUTSIDE OF ITS SPECIFIED VOLTAGE, THE MOTOR OVERHEATED AND STOPPED FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78598 NEB100 COMPRESSOR NEBULIZER CAF SUNSET HEALTHCARE SOLUTIONS NEB100 180223 00848530087326

    Patients

    Seq Age Sex Outcome Treatment
    1