BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINET ELEGANZA 3.

    MDR report key: 8414199 · Received March 12, 2019

    Report

    Report Number
    MW5084844
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 10, 2019
    Report Date
    March 6, 2019
    Manufacturer
    LINET SPOL, S.R.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT OF BED SPARKING WITH SMOKE ON (B)(6) 2019. NURSE MADE CODE RED CALL. PATIENT WAS MOVED TO ANOTHER ROOM. PLAN1: OPS RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208364 LINET ELEGANZA 3. BED, AC-POWERED ADJUSTABLE HOSPITAL FNL LINET SPOL, S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR