BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYE'S, INC DBA SIZEWISE MANUFACTURING

    MDR report key: 24769612 · Received April 2, 2026

    Report

    Report Number
    1954156-2026-00004
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 2, 2026
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FMR
    UDI-DI
    00845699000395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE BLOWER WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE OF POWER FAILURE. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. A BURN MARK APPROXIMATELY 9 INCHES BY 7 INCHES WAS OBSERVED ON THE PERCUSSION POWER SUPPLY BOARD EXTENDING TO THE BACK CASE AND SIDE PANEL OF THE BLOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832316 RAYE'S, INC DBA SIZEWISE MANUFACTURING ROTATE BLOWER FMR AGILITI HEALTH - ELLIS 61355009 00845699000395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown