BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 18986318 · Received March 27, 2024

    Report

    Report Number
    3013682457-2024-00002
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 27, 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.

    Description of Event or Problem · 0

    PATIENT WAS INITIALLY DIAGNOSED WITH AN UNSTAGEABLE PRESSURE INJURY ON (B)(6) 2024. THE LAST ASSESSMENT ON (B)(6) 2024 CLASSIFIED THE INJURY AS A STAGE 3. THE LOCATION OF THE INJURY IS ON THE NATAL CLEFT. THE REPORTING FACILITY INDICATED THEY USED A TOPICAL APPLICATION AND DRESSING TO TREAT THE PRESSURE INJURY. THE REPORTING FACILITY INDICATED THEY DO NOT BELIEVE THE GUARDIAN DEVICE CAUSED OR CONTRIBUTED TO THE INJURY OBSERVED ON THE PATIENT. INVESTIGATION OF THE AVAILABLE INFORMATION FROM THE GUARDIAN SYSTEM NOTED 8 INCIDENCES WHERE THE USING FACILITY DID NOT UTILIZE THE PAUSE FEATURE OF THE DEVICE FOR 12 CONSECUTIVE HOURS, WHICH CAN LEAD TO ENHANCER MIGRATION. ON (B)(6) 2024 THERAPY WAS PAUSED AND THEN RESUMED WITH THE ENHANCER POTENTIALLY MISPOSITIONED. THIS IS BASED ON A REVIEW OF THE GUARDIAN SYSTEM EVENT LOG INFORMATION, NOTING "SUSPECTED PATIENT MISPOSITION" EVENTS. THE DEVICE CONTINUED TO LOG SEVERAL MISPOSITION EVENTS UNTIL THE PATIENT WAS DISCHARGED ON (B)(6) 2024, RESULTING IN 48 HOURS OF LESS THAN OPTIMAL THERAPY. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527205 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention