BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINGUARD FLOAT

    MDR report key: 10891827 · Received November 24, 2020

    Report

    Report Number
    3003083675-2020-00408
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 16, 2020
    Report Date
    November 23, 2020
    Manufacturer
    KAP MEDICAL
    Product Code
    IOQ
    UDI-DI
    00817012021899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OWNER OF THE DEVICE, (B)(6), SENT A COMPLAINT ON 11/20/2020, THAT A MATTRESS DEFLATED, AND CAUSED DEEP TISSUE PRESSURE INJURY TO THE PATIENT. KAP MEDICAL REQUESTED THE DEVICE BE RETURNED FOR EVALUATION. THE MATTRESS IS DESIGNED WITH A SAFETY AIR CUSHION IN THE EVENT OF DEFLATION. THIS KEEPS THE PATIENT FROM BOTTOMING OUT. ADDITIONALLY, THE UNIT IS DESIGNED WITH A VISUAL AND AUDIBLE ALARM THAT WILL FLASH AND BEEP WHEN THE MATTRESS SENSES LOW INFLATION. THE INJURY WAS REPORTED TO (B)(6) ON (B)(6) 2020. KAP MEDICAL RECEIVED THE COMPLAINT ON 11/20/2020.

    Description of Event or Problem · 1

    PER REPORT RECEIVED FROM (B)(6) ON (B)(6) 2020, THE FACILITY DISCOVERED THE MATTRESS SUPPORTING THE PATIENT DEFLATED. THE CONTROL UNIT SHOWED A LOW PRESSURE WARNING AND ALARM. THE NURSE REPORTS THE PATIENT DEVELOPED DEEP TISSUE WOUND ON THE BUTTOCKS AS A RESULT OF THE DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358714 SKINGUARD FLOAT THERAPEUTIC SUPPORT SURFACE IOQ KAP MEDICAL SKINGUARDFLOATMS8 00817012021899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other