BEUDAMED
    FDA Adverse Event Death Summary report: N

    DOLPHIN FIS

    MDR report key: 17711690 · Received September 8, 2023

    Report

    Report Number
    3009402404-2023-00032
    Event Type
    Death
    Date Received
    September 8, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 7, 2023
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND RELEASE BY FDA OF THAT REPORT. INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT RECEIVED AN EMAIL FROM WCN AT (B)(6) THAT A PATIENT INCIDENT OCCURRED ON AN AGILITI RENTAL. THE PATIENT WS BEING PREPPED FOR HOSPICE AND FELL OUT OF BED WHICH RESULTED IN DEATH. COMPLAINT #(B)(4) AND RA #(B)(4) WAS ENTERED INTO OUR SYSTEM TO HAVE THE MATTRESS AND CONTROL UNIT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242673 DOLPHIN FIS PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE 900T-3582-M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death