BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINGUARD XM MATTRESS SYSTEM

    MDR report key: 10202493 · Received June 26, 2020

    Report

    Report Number
    3003083675-2020-00162
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 7, 2020
    Report Date
    June 10, 2020
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATTRESS IS MANUFACTURED BY KAP MEDICAL FOR AGILITI HEALTH. THE ADVERSE EVENT WAS REPORTED TO KAP MEDICAL BY AGILITI HEALTH ON 06/10/2020. LIMITED INFORMATION REGARDING PATIENT INFORMATION WAS RECEIVED. THERE IS NO INDICATION OF DEVICE MALFUNCTION AT THIS TIME. THE MATTRESS WAS ON THE PATIENT'S BED AT THE TIME OF THE EVENT. SINCE IT WAS REPORTED THAT THE PATIENT MAY HAVE SUSTAINED AN INJURY, THIS REPORT WAS SUBMITTED OUT OF CAUTION. THE BED THAT WAS USED IN CONJUNCTION WITH THE MATTRESS IS NOT MANUFACTURED OR SOLD BY KAP MEDICAL. THE PATIENT WAS REPORTED TO HAVE FALLEN FROM THE BED.

    Description of Event or Problem · 1

    RN REQUESTED A BARIATRIC BED FOR A NONBARIATRIC PATIENT BECAUSE THE RN FELT THE PATIENT NEEDED MORE ROOM. THE PATIENT REPORTEDLY FELL OUT OF THE BED. THE BED WAS NOT MANUFACTURED BY KAP MEDICAL. THE MATTRESS WAS AN AGILITI SKINGUARD XM MATTRESS, MANUFACTURED BY KAP MEDICAL. THERE IS NO INDICATION AT THIS TIME THAT THE MATTRESS CONTRIBUTED TO THIS EVENT. THIS REPORT IS BEING FILED IN CAUTION DUE TO THE MATTRESS BEING PRESENT ON THE BED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665126 SKINGUARD XM MATTRESS SYSTEM THERAPEUTIC SUPPORT SURFACE FNM KAP MEDICAL SKINGUARD XMS 170002469

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other