BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS BED 9153650455

    MDR report key: 4448390 · Received January 23, 2015

    Report

    Report Number
    1031452-2015-04454
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 1, 2014
    Report Date
    January 16, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY END USER THE MATTRESS IS FLIMSY. END USER ADVISED CONTACTED (B)(4) AND THEY SENT END USER AN OVERLAY FROM DRIVE BUT STILL HAVING THE ISSUE OF WHEN LAYS ON THE BED IT SINKS DOWN IN THE MIDDLE ABOUT 10 TO 15 INCHES. END USER ADVISED WHEN HE LAYS ON THE MATTRESS IT GOES COMPLETELY FLAT. END USER ADVISED HAVE BACK ISSUES AND IS UNCOMFORTABLE. END USER ADVISED BEFORE OVER LAY COULD FEEL SPRINGS WHEN LYING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54995 CS BED 9153650455 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other