BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 21070385 · Received January 3, 2025

    Report

    Report Number
    3013682457-2025-00001
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    November 3, 2024
    Report Date
    January 3, 2025
    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

    THIS INJURY WAS DISCOVERED BY TURNCARE THROUGH A REVIEW OF HOSPITAL HAPI REPORT INFORMATION. THERE WAS NO ALLEGATION FROM THE CUSTOMER THAT THE GUARDIAN SYSTEM CAUSED OR CONTRIBUTED TO THE PRESSURE INJURY EVENT. INVESTIGATION WAS CONDUCTED ON THE AVAILABLE INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, A STAGE 3 PRESSURE INJURY WAS OBSERVED ON THE SACRUM BY THE FACILITY. THERE WAS NO INDICATION OF INJURY PROGRESSION OR WHAT, IF ANY, ADDITIONAL TREATMENT WAS REQUIRED FOR THE PRESSURE INJURY. REVIEW OF THE GUARDIAN SYSTEM CONTROLLER DATA NOTED "LEAK ALERT" EVENTS PRIOR TO THE INJURY EVENT OCCURRENCE, RESULTING IN THE CONTROLLER PROMPTING THE HEALTHCARE PROFESSIONAL TO TAKE ACTION TO REPLACE THE SURFACE. THE "LEAK ALERT" EVENTS WERE MANUALLY CLEARED BY THE USER WITHOUT REPLACEMENT OF THE SURFACE DURING THE TIME PERIOD LEADING UP TO THE PRESSURE INJURY DISCOVERY. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE AN UPDATE TO THIS REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431494 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. G2S 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown