BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINET

    MDR report key: 12273619 · Received August 4, 2021

    Report

    Report Number
    12273619
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 25, 2021
    Manufacturer
    LINET AMERICAS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WELD IS FAILING ON KNEE GATCH ON LINET BEDS CAUSING THE BED TO NEED REPAIR. IN SOME INSTANCES THE PATIENTS MUST BE MOVED BECAUSE THE FOOT OF THE BED GOES PASSED THE STOPPING POINT AND CUTS ALL THE MECHANICAL WIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174690 LINET BED, AC-POWERED ADJUSTABLE HOSPITAL FNL LINET AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1