BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINGUARD MATTRESS SYSTEM

    MDR report key: 10197701 · Received June 25, 2020

    Report

    Report Number
    3003083675-2020-00137
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 25, 2020
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    UDI-DI
    00817012022209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS MANUFACTURED BY KAP MEDICAL FOR (B)(4). THE ADVERSE EVENT WAS REPORTED TO KAP MEDICAL BY (B)(4) ON (B)(6) 2020. THERE IS NO INDICATION OF DEVICE MALFUNCTION AT THIS TIME. THE DEVICE (MATTRESS SYSTEM) WAS ON THE PATIENT'S BED AT THE TIME OF THE EVENT. SINCE IT WAS REPORTED THAT THE PATIENT MAY HAVE SUSTAINED INJURY, THIS REPORT WAS SUBMITTED OUT OF CAUTION. THE BED THAT WAS USED WAS NOT MANUFATURED OR SOLD BY KAP MEDICAL.

    Description of Event or Problem · 1

    THE INCIDENT WAS REPORTED TO KAP MEDICAL BY (B)(6) ON (B)(4) 2020. THE REPORT STATES THAT THE RN ENTERED THE PATIENT ROOM AT APPROX. 2 AM AND FOUND THE PATIENT ON THE GROUND KNEELING NEXT TO THE BED. THE BED (UMANO MEDICAL OOK SNOW BARIATRIC BED 200-0000) EXIT ALARM WAS NOT SET BECAUSE THE RN STATED THAT SHE DID NOT KNOW HOW TO SET IT. IT IS UNKNOWN IF THE PATIENT FELL. THE EVENT OCCURED AT (B)(6) HOSPITAL CENTRAL IN (B)(6). THE MATTRESS WAS MANUFACTURED BY KAP MEDICAL FOR (B)(4). THE MATTRESS WAS A SKINGUARD XMS MATTRESS SYSTEM. THE BED WAS NOT MANUFACTURED BY KAP MEDICAL. THERE WERE NO INITIAL REPORTS THAT THE MATTRESS CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657358 SKINGUARD MATTRESS SYSTEM THERAPEUTIC SUPPORT SURFACE FNM KAP MEDICAL SKNGUARD88MS8EL 200000374 00817012022209

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other