BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOLPHIN FIS

    MDR report key: 21229858 · Received January 24, 2025

    Report

    Report Number
    3009402404-2024-00049
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 22, 2024
    Report Date
    January 24, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    UDI-DI
    00857268006738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PER AGILITI, ACCORDING TO THE SUPERVISOR AT (B)(6) HOSPITAL IN MIAMI, PATIENT FELL OFF BEDFRAME. ALL FOUR SIDERAILS WERE UP, ALARM WAS ON AND ALERTED THE FLOOR WHEN THE PATIENT FELL. PATIENT WAS ON JOERNS MANUFACTURED DOLPHIN FIS MATTRESS AND CONTROL UNIT. AGILITI WILL PERFORM TESTING. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742326 DOLPHIN FIS PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DLPH-3582NCOOJ-M 00857268006738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other