BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 18914923 · Received March 15, 2024

    Report

    Report Number
    3013682457-2024-00001
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    January 9, 2024
    Report Date
    March 15, 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. THE DATA COLLECTED NOTED THE LEAK ALERT CONDITION, WHICH WENT UNRESOLVED UNTIL THE PATIENT WAS TRANSFERRED DESPITE ATTEMPTS BY THE TURNCARE TEAM TO CONTACT THE BEDSIDE NURSE. NOTE: ACCESS TO EMDR SUBMISSION PROCESS IN THE PRODUCTION ENVIRONMENT WAS GRANTED TO TURNCARE ON 3/14/2024 (REFERENCE ESG TICKET (B)(4)).

    Description of Event or Problem · 0

    PATIENT WAS DIAGNOSED WITH A STAGE 3 PRESSURE INJURY ON THE BUTTOCKS. THERE WAS NO INDICATION FROM THE USING FACILITY WHETHER FURTHER TREATMENT OR INTERVENTION WAS REQUIRED AS A RESULT. THERE WAS ALSO NO DOCUMENTATION OF THE INJURY GETTING WORSE, OR THAT ANY ADDITIONAL COMPLICATIONS OCCURRED AS A RESULT OF THE STAGE 3 PRESSURE INJURY. INVESTIGATION OF THE AVAILABLE INFORMATION NOTED A LEAK ALERT REGISTERED IN THE GUARDIAN DEVICE DURING USE BY THIS PATIENT, AND THE SYSTEM CONTINUED TO ALERT UNTIL THE PATIENT WAS TRANSFERRED DESPITE ATTEMPTS BY THE TURNCARE TEAM TO CONTACT THE BEDSIDE NURSE. THE GUARDIAN DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130775 GUARDIAN 2 SYSTEM ALTERNATING PRESSSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male