BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 12158788 · Received July 13, 2021

    Report

    Report Number
    3012316249-2021-00022
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    INN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHEN THE END USER PLUGGED THIS SEAT IN FOR THE FIRST TIME, IT 'STARTED SMOKING' AND WOULD NOT LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056373 COMPASS HEALTH BRANDS UL PREMIUM POWER SEAT 20" INN COMPASS HEALTH BRANDS CCFPS3020

    Patients

    Seq Age Sex Outcome Treatment
    1