MalfunctionFMR
RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Apr 2, 2026 · Event occurred Mar 9, 2026
Report 1954156-2026-00004 · MDR key 24769612
Device
Product problems
- Electrical Overstress
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A CORRECTIVE AND PREVENTATIVE ACTION CAPA: 01205 HAS BEEN INITIATED TO THOROUGHLY INVESTIGATE THE ISSUE AND IDENTIFY THE ROOT CAUSE.
Description of Event or Problem
THE BLOWER WAS SENT TO AGILITI FOR REPAIR WITH THE REPORTED ISSUE OF POWER FAILURE. UPON OPENING THE DEVICE, AN AGILITI TECHNICIAN DISCOVERED INTERNAL BURN DAMAGE THAT CAUSED THE POWER FAILURE. A BURN MARK APPROXIMATELY 9 INCHES BY 7 INCHES WAS OBSERVED ON THE PERCUSSION POWER SUPPLY BOARD EXTENDING TO THE BACK CASE AND SIDE PANEL OF THE BLOWER.