MalfunctionFMR
RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Jan 22, 2026 · Event occurred Dec 23, 2025
Report 1954156-2026-00002 · MDR key 24146676
Device
Product problems
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY VIA COMPLAINT: (B)(4).
Description of Event or Problem
THE PUMP WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE THAT THE UNIT HAD NO POWER. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. THE BURN MARK WAS LOCATED ON THE POWER BOARD AND MEASURED APPROXIMATELY 1 CM IN DIAMETER.