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

Model Number	61355006
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A corrective and preventative action capa-01205 has been initiated to thoroughly investigate the issue and identify the root cause.
Event or Problem Description
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.Burn damage was observed on the side panel assembly, and a mark approximately 6 inches in length was present on the interior surface of the unit.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: ALTERNATE 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: bethany schultz ; 204 w 2nd st; ellis, KS 67637
• MDR Report Key: 24551961
• Report Number: 1954156-2026-00003
• Device Sequence Number: 5689214
• Product Code: FMR
• UDI-Device Identifier: 00845699000388
• UDI-Public: 00845699000388
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 61355006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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