BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITI/SIZEWISE ENVY - 2020

    MDR report key: 20323099 · Received September 26, 2024

    Report

    Report Number
    MW5160196
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    VA PUGET SOUND HCS IS COMPLETING INSPECTIONS OF ALL HOSPITAL BED AND GURNEY SURFACES PER A NATIONAL PATIENT SAFETY ALERT. THE FOLLOWING WAS INSPECTED: EXTERNAL COVER, ZIPPER, INSIDE OF COVER, MICROHOLES, FAILURE-ODORS, INTERNAL MATERIALS, FIRE BARRIER. SURFACE FOUND TO BE COMPROMISED: TOP COVER ONLY AREA FOUND TO BE COMPROMISED: EXTERNAL COVER / INSIDE OF COVER / MICROHOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997584 AGILITI/SIZEWISE ENVY - 2020 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM AGILITI HEALTH - ELLIS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown