BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19018710 · Received April 2, 2024

    Report

    Report Number
    3013682457-2024-00006
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    September 10, 2022
    Report Date
    April 2, 2024
    Manufacturer
    TURNCARE, INC.
    Product Code
    FNM
    UDI-DI
    00860001236453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. A DTPI WAS OBSERVED IN THE SACRUM/NATAL CLEFT AREA ON (B)(6) 2022. NO FURTHER INFORMATION ON TREATMENT OF THE DTPI WAS PROVIDED. EVALUATION OF GUARDIAN DATA NOTED SEVERAL GAPS IN THERAPY, INCLUDING A TOTAL OF 19 HOURS 5 MINS DUE TO ENHANCER DISCONNECT. THIS INCLUDED 4 EPISODES, TOTALING 8HRS 22 MINS BETWEEN (B)(6) 2022. IT WAS ALSO NOTED THE INCORRECT PATIENT WEIGHT RANGE WAS SELECTED (SELECTED RANGE WAS 126-136KG). THERE WERE NO INDICATIONS OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594583 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female