BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAP MEDICAL MATRESS

    MDR report key: 20514073 · Received October 22, 2024

    Report

    Report Number
    MW5161425
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Report Date
    October 16, 2024
    Manufacturer
    KAP MEDICAL
    Product Code
    FNL
    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 51 MATTRESSES WERE FOUND WITH INTEGRITY COMPROMISE. THE BREAKDOWN IS AS FOLLOWS: STRYKER PIONEER-3, HILL-ROM ACCUMAX-4, HILL-ROM CENTRELLA MAX-5, ENVY LINE-2, HILL-ROM-15, STRYKER-6, HILL-ROM STRETCHER-1, HILL-ROM NANO AG+-1, HILL LINE-2, ATMOS AIR-1, KAP MEDICAL-1, MENTAL HEALTH SAFETY MATTRESSES-10. REFERENCE REPORT NUMBER #MW5161385, #MW5161386, #MW5161387, #MW5161388, #MW5161389 #MW5161390, #MW5161391, #MW5161392, #MW5161393, #MW5161394, #MW5161395, #MW5161396, #MW5161397, #MW5161398, #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, #MW5161426, #MW5161428, #MW5161429, #MW5161430, #MW5161431, #MW5161432, #MW5161433, #MW5161434, #MW5161435, #MW5161436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351939 KAP MEDICAL MATRESS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL KAP MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown