BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVY LINE

    MDR report key: 20513746 · Received October 22, 2024

    Report

    Report Number
    MW5161398
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Report Date
    October 16, 2024
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING OUR 100% MATTRESS/STRETCHER MATTRESSES AUDIT (B)(4) MATTRESSES WERE FOUND WITH INTEGRITY COMPROMISE. THE BREAKDOWN IS AS FOLLOWS: STRYKER PIONEER(B)(4), HILL-ROM ACCUMAX(B)(4) HILL-ROM CENTRELLA MAX(B)(4) ENVY LINE(B)(4), HILL-ROM(B)(4), STRYKER(B)(4), HILL-ROM STRETCHER(B)(4), HILL-ROM NANO AG(B)(4), HILL LINE(B)(4), ATMOS AIR(B)(4), KAP MEDICAL(B)(4), MENTAL HEALTH SAFETY MATTRESSES(B)(4). REFERENCE REPORT NUMBER #MW5161385, #MW5161386, #MW5161387, #MW5161388, #MW5161389 #MW5161390, #MW5161391, #MW5161392, #MW5161393, #MW5161394, #MW5161395, #MW5161396, #MW5161397, #MW5161399, #MW5161400, #MW5161401, #MW5161402, #MW5161403, #MW5161404, #MW5161405, #MW5161406, #MW5161407, #MW5161408, #MW5161409, #MW5161410, #MW5161411, #MW5161412, #MW5161413, #MW5161414, #MW5161415, #MW5161416, #MW5161417, #MW5161418, #MW5161419, #MW5161420, #MW5161421, #MW5161422, #MW5161423, #MW5161424, #MW5161425, #MW5161426, #MW5161428, #MW5161429, #MW5161430, #MW5161431, #MW5161432, #MW5161433, #MW5161434, #MW5161435, #MW5161436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568514 ENVY LINE MATTRESS, FLOTATION THERAPY, NON-POWERED IKY AGILITI HEALTH - ELLIS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown