BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19115706 · Received April 16, 2024

    Report

    Report Number
    3013682457-2024-00008
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 9, 2024
    Report Date
    April 16, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS CONDUCTED ON THE REPORTED INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE. INVESTIGATION INTO THE GUARDIAN SYSTEM DATA FOR THE 48 HOURS PRECEDING THE INJURY SUGGESTS THE ENHANCER WAS NOT POSITIONED PROPERLY UNDERNEATH THE PATIENT. THE INVESTIGATION CONDUCTED BY TURNCARE REVEALED NO EVIDENCE OF DEFECTS, FAILURES, OR MALFUNCTIONS OF THE DEVICE.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL WITH PANCYTOPENIA ON (B)(6) 2024. PATIENT WAS INITIALLY DIAGNOSED WITH A DTI ON 09-MAR-2024, WHICH EVOLVED TO A STAGE 3 INJURY ASSESSED ON 15-MAR-2024. THE REPORTED ESCALATION TO STAGE 3 OCCURRED 4 DAYS AFTER THE PATIENT WAS NO LONGER ENROLLED ON THE GUARDIAN SYSTEM. INITIAL REPORT FROM THE HOSPITAL CONTACT INDICATED "SKIN INDENTATIONS FROM THE TURNCARE MAT WERE PALPABLE UPON ROLLING THE PATIENT". THE INITIAL BELIEF FROM THE HOSPITAL WAS THE INDENTATIONS WERE FROM THE TUBING OF THE ENHANCER. ADDITIONAL FOLLOW UP FROM THE HOSPITAL WOUND CARE RN COULD NOT BE CERTAIN WHETHER THE WOUND WAS CAUSED BY THE TURNCARE DEVICE. BASED ON A REVIEW OF INJURY PHOTOS, TURNCARE MEDICAL PERSONNEL DO NOT BELIEVE THE WOUND WAS CAUSED BY THE ENHANCER TUBING SINCE THE NATURE OF THE WOUND IS NOT CONSISTENT WITH WHAT WOULD BE EXPECTED FROM ONE CAUSED BY IMPRESSION FROM THE ENHANCER TUBING. WHEN USED ACCORDING TO TURNCARE STANDARD EDUCATION AND BEST PRACTICE, THE TUBING DOES NOT COME IN CONTACT WITH THE PATIENT'S SKIN. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445950 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male