BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYE'S, INC DBA SIZEWISE MANUFACTURING

    MDR report key: 23926998 · Received December 30, 2025

    Report

    Report Number
    1954156-2025-00014
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    May 29, 2025
    Report Date
    December 30, 2025
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FMR
    UDI-DI
    00845699000371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTIVE AND PREVENTIVE ACTION CAPA-01205 HAS BEEN INITIATED TO THOROUGHLY INVESTIGATE THE ISSUE AND IDENTIFY THE ROOT CAUSE.

    Description of Event or Problem · 0

    DEVICE WAS SENT IN FOR REPAIR AND UPON OPENING THE UNIT, THE TECHNICIAN FOUND BURN DAMAGE INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328243 RAYE'S, INC DBA SIZEWISE MANUFACTURING PULSATE BLOWER FMR AGILITI HEALTH - ELLIS 61355002 00845699000371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown