RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received May 8, 2025 · Event occurred Apr 9, 2025
Report 1954156-2025-00011 · MDR key 21985546
Device
Product problems
- Electrical Overstress
- Electrical Overstress
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BLOWER WAS EVALUATED, AND IT WAS DETERMINED THAT THE CAPACITOR LOCATED ON THE SIDE PANEL, ADJACENT TO THE POWER ENTRY MODULE, HAD SUSTAINED BURN DAMAGE. NO EXTERNAL DAMAGE WAS OBSERVED. A CORRECTIVE AND PREVENTIVE ACTION CAPA-01205 HAS BEEN INITIATED TO THOROUGHLY INVESTIGATE THE ISSUE AND IDENTIFY THE ROOT CAUSE.
Description of Event or Problem
THE PUMP WAS SENT TO AGILITI'S CENTER OF EXCELLENCE (COE) FOR REPAIR OF A COMPONENT UNRELATED TO THIS ISSUE. DURING DEVICE INSPECTION, THE COE IDENTIFIED BURN MARKS INSIDE THE PUMP; NO EXTERIOR DAMAGE WAS FOUND. NO COMPLAINTS OR REPORTS REGARDING THIS ISSUE WERE FILED BY THE CUSTOMER.