BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19018688 · Received April 2, 2024

    Report

    Report Number
    3013682457-2024-00003
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    April 13, 2023
    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 # LVHN IPCU). 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) 2023. PATIENT'S STAGE 2 ON NATAL CLEFT PROGRESSED TO UNSTAGEABLE ON (B)(6) 2023. EVALUATION OF GUARDIAN DATA WAS COMPILED FOR DATES PRIOR TO HAPI DISCOVERY. A TOTAL GAP IN THERAPY OF 143.5 HOURS WAS REVIEWED, WHICH INCLUDED: 12.5 HOURS OF DISCONNECTED ENHANCER, 92 HOUR DELAY IN THERAPY WHEN TRANSFERRING BETWEEN UNITS, 34.5 HOURS OF NO PATIENT DETECTED/MISPOSITIONED ENHANCER, AND 4.5 HOURS OF THE PAUSE FEATURE RUNNING FOR THE FULL 30 MINUTES. THERE WERE ALSO 14.5 TOTAL DAYS UTILIZING THE DEVICE WITH AN INCORRECT WEIGHT SELECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866420 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female