BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARISE LAL

    MDR report key: 22929798 · Received September 2, 2025

    Report

    Report Number
    3009402404-2025-00040
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 6, 2025
    Report Date
    August 29, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    UDI-DI
    00810055881000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMATION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND 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, NURSE STATED THAT THE MATTRESS WAS EXTREMELY WARM BUT THE CONTROLLER WAS NOT. NO INJURY TO PATIENT. AGILITI WILL PERFORM THE TESTING. COMPLAINT # (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879977 ARISE LAL PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE AREXLAL-4888NZ 00810055881000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other