BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYE'S, INC DBA SIZEWISE MANUFACTURING

    MDR report key: 21989358 · Received May 8, 2025

    Report

    Report Number
    1954156-2025-00012
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 8, 2025
    Manufacturer
    AGILITI HEALTH - ELLIS
    Product Code
    FMR
    UDI-DI
    00845699000395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLOWER WAS EVALUATED, AND IT WAS DETERMINED THAT THE CAPACITOR LOCATED ON THE SIDE PANEL, ADJACENT TO THE POWER ENTRY MODULE, HAD SUSTAINED BURN DAMAGE. NO EXTERNAL DAMAGE WAS OBSERVED. 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

    THE PUMP WAS SENT TO AGILITI'S CENTER OF EXCELLENCE (COE) FOR REPAIR OF A COMPONENT UNRELATED TO THIS ISSUE. DURING DEVICE INSPECTION, THE COE IDENTIFIED BURN MARKS INSIDE THE PUMP; NO EXTERIOR DAMAGE WAS FOUND. NO COMPLAINTS OR REPORTS REGARDING THIS ISSUE WERE FILED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946263 RAYE'S, INC DBA SIZEWISE MANUFACTURING ROTATE BLOWER FMR AGILITI HEALTH - ELLIS 61355009 00845699000395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown