BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19018709 · Received April 2, 2024

    Report

    Report Number
    3013682457-2024-00007
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    December 7, 2022
    Report Date
    April 2, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED BASED ON A RETROSPECTIVE REVIEW (REFERENCE RCA # (B)(4). INVESTIGATION WAS CONDUCTED ON THE REPORTED INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE AVAILABLE AT THE TIME.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED ON (B)(6) 2022. PATIENT WAS DISCHARGED OFF THE GUARDIAN SYSTEM ON (B)(6) 2022 AND NOT RE-ENROLLED FOR THE DURATION OF THEIR STAY. ON (B)(6) 2022, A STAGE 2 PRESSURE INJURY WAS OBSERVED TO THE SACRAL REGION, WHICH PROGRESSED TO A STAGE 3 INJURY AS OF (B)(6) 2022. NO FURTHER INFORMATION ON TREATMENT OF THE PRESSURE INJURY WAS PROVIDED. IT IS NOTED THE PRESSURE INJURY WAS OBSERVED TWO DAYS AFTER THE PATIENT WAS DISCHARGED OFF THE GUARDIAN SYSTEM WITHOUT RE-ENROLLMENT. EVALUATION OF GUARDIAN DATA NOTED SEVERAL GAPS IN THERAPY, INCLUDING SEVERAL GAPS DUE TO PATIENT DISCHARGES FROM THE SYSTEM (GREATER THAN 92 TOTAL HOURS). THERE WERE NO INDICATIONS OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594582 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown