MAUDE Adverse Event Report: AGILITI HEALTH - ELLIS RAYE'S, INC DBA SIZEWISE MANUFACTURING; ROTATE BLOWER

Model Number	61355009
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: ROTATE BLOWER
• Manufacturer (Section D): AGILITI HEALTH - ELLIS; 204 w 2nd st; ellis KS 67637
• Manufacturer (Section G): AGILITI HEALTH - ELLIS; 204 w 2nd st; ellis KS 67637
• Manufacturer Contact: kari brower ; 204 w 2nd st; ellis, KS 67637
• MDR Report Key: 21989358
• Report Number: 1954156-2025-00012
• Device Sequence Number: 8480307
• Product Code: FMR
• UDI-Device Identifier: 00845699000395
• UDI-Public: 00845699000395
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 61355009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown