BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 21503732 · Received March 3, 2025

    Report

    Report Number
    3013682457-2025-00002
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 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 (B)(6) REPORT INFORMATION. THERE WAS NO ALLEGATION FROM THE CUSTOMER THAT THE GUARDIAN SYSTEM CAUSED OR CONTRIBUTED TO THE PRESSURE INJURY EVENT.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025 A DTI WAS OBSERVED ON THE ISCHIUM 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 SHOWED INCIDENCES OF TERMINAL BATTERY SHUTDOWNS OF THE CONTROLLER, RESULTING IN TIMES WHERE THE GUARDIAN SYSTEM WAS NOT RUNNING. THE TERMINAL BATTERY EVENTS OCCURRED IF THE CONTROLLER WAS UNPLUGGED FROM AC POWER, AND WHEN THIS OCCURRED THE TERMINAL BATTERY SOFTWARE WARNINGS/ALERTS, PROMPTING ACTION TO THE USER, WERE OPERATING PROPERLY. WHEN CONNECTED TO AC POWER, THE CONTROLLER OPERATED CONTINUALLY WITHOUT ISSUE. THE ASSOCIATED CONTROLLER WAS EVENTUALLY RETURNED TO TURNCARE FOR SERVICE AT WHICH TIME THE POWER SUPPLY WAS REPLACED. 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
    585661 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown