FDA Adverse Event
Malfunction
Summary report: N
RAYE'S, INC DBA SIZEWISE MANUFACTURING
MDR report key: 25257538
·
Received May 22, 2026
Report
- Report Number
- 1954156-2026-00005
- Event Type
- Malfunction
- Date Received
- May 22, 2026
- Date of Event
- March 3, 2026
- Report Date
- May 22, 2026
- Manufacturer
- AGILITI HEALTH - ELLIS
- Product Code
- FMR
- UDI-DI
- 00845699000432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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).
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485264 | RAYE'S, INC DBA SIZEWISE MANUFACTURING | SAPPHIRE PULSE BLOWER | FMR | AGILITI HEALTH - ELLIS | 61350002 | 00845699000432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |