BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE GUARD

    MDR report key: 21294483 · Received January 31, 2025

    Report

    Report Number
    MW5165541
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Report Date
    January 29, 2025
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN AUDIT OF 100% OF MATTRESS IN FACILITY REVEALED 4 MODELS FAILED DUE TO NOTED STAINING ON THE INNER FOAM MATTRESSES. STRYKER ISO LIBRIUN, SPAN AMERICA PRESSURE GUARD, LINET PROTEVO APC, AND ACU MAX QUANTUM VPC PRS. ALL MATTRESSES WERE DISPOSED OF AND REPLACED. NO PATIENT INJURY. REFERENCE REPORTS MW5165540, MW5165542, MW5165543.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246642 PRESSURE GUARD MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM SPAN-AMERICA MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown