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

Model Number	61355002
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A corrective and preventive action capa-01205 has been initiated to thoroughly investigate the issue and identify the root cause.
Event or Problem Description
Device was sent in for repair and upon opening the unit, the technician found burn damage internally.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: PULSATE 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: 23926998
• Report Number: 1954156-2025-00014
• Device Sequence Number: 8825321
• Product Code: FMR
• UDI-Device Identifier: 00845699000371
• UDI-Public: 00845699000371
• 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): 12/30/2025

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: 61355002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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