BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 20113693 · Received August 30, 2024

    Report

    Report Number
    3013682457-2024-00012
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 30, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    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.

    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 BUTTOCKS 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. REPLACEMENT OF THE BED SURFACE WAS DELAYED BY THE HEALTHCARE PROFESSIONAL BASED ON THEIR JUDGMENT OF PATIENT CONDITIONS AND TREATMENT OPTIONS. IT WAS REPORTED THE PATIENT HAD AN ACUTE RESPIRATORY ILLNESS, EXPERIENCED PAIN AND OXYGEN DESATURATION WITH MOVEMENT, AND WAS REFUSING STANDARD PATIENT TURN PRACTICES. THE ASSOCIATED CONTROLLER WAS EVENTUALLY RETURNED TO TURNCARE FOR SERVICE AT WHICH TIME A MANIFOLD VALVE 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
    847655 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown