MalfunctionFMR
RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received May 22, 2026 · Event occurred Mar 3, 2026
Report 1954156-2026-00005 · MDR key 25257538
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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).
Description of Event or Problem
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.