BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIOSO INTEGRATED LOW AIR LOSS MATTRESS

    MDR report key: 3851399 · Received May 29, 2014

    Report

    Report Number
    MW5036457
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    LINET AMERICAS
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTER COVER OF THE SYMBIOSO MATTRESS FAILED TO PREVENT BODILY FLUID FROM LEAKING INTO THE BODY OF THE MATTRESS. FLUID LEAKAGE HAS BEEN FOUND ON MULTIPLE OCCASIONS BY (B)(6)DURING CLEANING OF BEDS IN THE INTENSIVE CARE UNIT. HAD THIS LEAKAGE NOT BEEN FOUND, POTENTIAL EXISTS TO PLACE A NEW PT ON A MATTRESS THAT CONTAINS BODILY FLUID FROM A PREVIOUS PT. MULTIPLE COMPLAINTS HAVE BEEN LODGED WITH THE MANUFACTURER OF THE MATTRESS. FLUID LEAKED THROUGH THE TOP COVER, PAST THE AIR BLADDERS THROUGH A FOAM FILLED LAYER TO THE VERY BOTTOM OUTER COVER OF THE MATTRESS. WE HAVE PROVIDED PREVIOUS SAMPLES OF FAILED COVERS TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317365 SYMBIOSO INTEGRATED LOW AIR LOSS MATTRESS LOW AIR LOSS MATTRESS FNM LINET AMERICAS 3VS0SD0220000

    Patients

    Seq Age Sex Outcome Treatment
    1