BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOLPHIN FIS

    MDR report key: 23193080 · Received October 1, 2025

    Report

    Report Number
    3009402404-2025-00045
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 25, 2025
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 - CORD TO BED WAS FRAYED ON THE UMANO BED TEH0610 (NON-JOERNS MANUFACTURED). WHEN THE STAFF PLUGGED IT IN, SPARKS CAME FROM THE CORD. IT SHORTED THE ELECTRICITY FOR THE ENTIRE HOSPITAL ROOM. THERE WAS NO PATIENT INJURY, THOUGH A NURSE WAS SHOCKED WHEN PLUGGING THE BED INTO THE OUTLET. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216702 DOLPHIN FIS PATIENT AIR MATTRESS FNM JOERNS HEALTHCARE DLPH-4882LPOOJ-M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other