BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR BRACKETS RIGHT

    MDR report key: 10390155 · Received August 11, 2020

    Report

    Report Number
    3007802293-2020-00014
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    October 15, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY PHOTOS AND A DESCRIPTION WERE SENT TO THE PROJECT MANAGEMENT GROUP, WHO IDENTIFIED SEVERAL ISSUES WITH THE INSTALLATION. HANDICARE VISITED THE HOME AND CONFIRMED SEVERAL ISSUES. THE INSTALLATION ISSUES IDENTIFIED, MOST SIGNIFICANTLY THE LONG RODS WITHOUT LATERAL BRACING, ALLOWED THE RAIL PIECES TO SEPARATE ENOUGH FOR THE UNIT TO TRAVEL OUT OF THE TRACK. THESE ISSUES WOULD BE NOTICEABLE TO THE USER. THE ROOT CAUSE OF THIS INCIDENT IS INSTALLATION ERROR. THE CEILING LIFT WAS REPLACED WITH A NEW UNIT. ON (B)(6) 2020, HANDICARE REPLACED SEVERAL COMPONENTS TO STABILIZE THE SYSTEM, UNTIL THE FULL SYSTEM COULD BE REPLACED COMPLETED (B)(6) 2020. THE COMPANY RESPONSIBLE FOR THE ORIGINAL INSTALLATION OF THE SYSTEM IS NO LONGER IN BUSINESS. THE INSTALLATION MANUAL IS WELL DESCRIBED. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A C-450 UNIT FELL OUT OF THE CEILING TRACK SYSTEM WHILE IN USE. THE USER FELL TO THE FLOOR AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855052 CONNECTOR BRACKETS RIGHT CEILING TRACK ACCESSORY FSA HANDICARE USA INC. 360465

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR