BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19018692 · Received April 2, 2024

    Report

    Report Number
    3013682457-2024-00004
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    August 1, 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 # (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) 2023. THE PATIENT WEIGHT RANGE SELECTION FOR THE GUARDIAN DEVICE WAS 81-91KG. ON (B)(6) 2023, A DTI WAS IDENTIFIED ON THE PATIENT. THERE WAS NO FURTHER INDICATION OF INJURY PROGRESSION OR WHAT TREATMENT, IF ANY, WAS REQUIRED TO TREAT THE DTI. EVALUATION OF GUARDIAN DATA LEADING UP TO THE DTI DISCOVERY WAS PERFORMED. A TOTAL DELAY OF 19.5 HOURS IN TIME TO INITIATE THERAPY WAS NOTED, AND POTENTIALLY 12.3 HOURS OF GAPS IN THERAPY WAS ALSO NOTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867393 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown