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

Model Number	61350002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Agiliti was initially unable to confirm whether the device was manufactured by agiliti or to identify the specific unit involved until personnel went on site to visually confirm on (b)(6) 2026.Initial assessment indicates evidence consistent with a thermal event, but no immediate damage was noted in the unit.Root cause analysis is currently underway via (b)(4).
Event or Problem Description
The blower's control panel is exhibiting discoloration (turning black) and emitting a hot odor.The device remained operational; however, it was noted to feel hot during use.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: SAPPHIRE PULSE 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: 25257538
• Report Number: 1954156-2026-00005
• Device Sequence Number: 18776942
• Product Code: FMR
• UDI-Device Identifier: 00845699000432
• UDI-Public: 00845699000432
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 61350002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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