BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS (THE BTE WS30)

    MDR report key: 4531685 · Received February 18, 2015

    Report

    Report Number
    1119903-2015-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 19, 2015
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    ISD
    PMA / PMN Number
    K933611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEED TO RETURN THE DEVICE OR THE DEVICE COMPONENTS TO BTE AS THE PROBLEM IS NOT RELATED TO NONCONFORMING PARTS. THE INVESTIGATION IS BEING CONDUCTED USING PARTS FROM INVENTORY. THE PROBLEM CANNOT OCCUR WITH ANY OTHER TOOL OR ATTACHMENT.

    Description of Event or Problem · 1

    NO INJURY WAS REPORTED. IN SPECIFIC USE SCENARIOS ONE OF THE PRIMUS TOOLS, THE CHOP LIFT BAR, COULD GET ACCIDENTALLY DISENGAGED FROM THE CONNECTING HOOK THAT MIGHT CAUSE THE CLIENT TO LOSE BALANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115137 PRIMUS (THE BTE WS30) EXERCISER, MEASURING ISD BTE TECHNOLOGIES, INC. PRIMUSRS (PRRS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other