BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYE'S, INC DBA SIZEWISE MANUFACTURING

    MDR report key: 24146676 · Received January 22, 2026

    Report

    Report Number
    1954156-2026-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 22, 2026
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FMR
    UDI-DI
    00845699003624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY VIA COMPLAINT: (B)(4).

    Description of Event or Problem · 0

    THE PUMP WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE THAT THE UNIT HAD NO POWER. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. THE BURN MARK WAS LOCATED ON THE POWER BOARD AND MEASURED APPROXIMATELY 1 CM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211642 RAYE'S, INC DBA SIZEWISE MANUFACTURING 120V PLATINUM 6000 FMR AGILITI HEALTH - ELLIS 61600050 00845699003624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown