BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED CEILING LIFT

    MDR report key: 2971633 · Received February 11, 2013

    Report

    Report Number
    2971633
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 8, 2013
    Manufacturer
    PRISM MEDICAL
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    THE LIFT WAS BEING USED TO MOVE A PATIENT WHEN IT WAS NOTED THAT THE PLASTIC PIECE THAT COVERS THE CONNECTION OF THE MAIN SUPPORTING STRAP WAS SPLIT. IT APPEARED AS THOUGH A FAILURE OF THE STRAP CONNECTION TO THE PATIENT SUPPORT STRUCTURE WAS OCCURRING THAT MIGHT RESULT IN THE PATIENT BEING DROPPED.======================MANUFACTURER RESPONSE FOR PATIENT CEILING MOUNTED LIFT., (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THIS PROBLEM HAD BEEN OBSERVED ELSEWHERE AND THE MANUFACTURER WOULD REPLACE ALL UNITS WITH THE PLASTIC COVER WITH NEW UNITS HAVING A METAL COVER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MOVEMENT OF A PATIENT BETWEEN THE BED AND THE BATHROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60486 FIXED CEILING LIFT LIFT, PATIENT FNG PRISM MEDICAL C-625 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *