MalfunctionIRT
31-HP800-0, 12" X 24" HEATING PAD
Received May 27, 2025 · Event occurred Apr 25, 2025
Report MW5170737 · MDR key 22087294
Device
Generic name
Pad, Heating, Powered
Manufacturer
Fresenius Medical CareProduct problems
- Thermal Decomposition of Device
- Device Emits Odor
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE STATING THAT THE 31-HP800-0, 12" X 24" HEATING PAD, THREE SETTING WENT BAD, IT IS BURNT ON THE SIDES AND SMELLS OF PLASTIC. THE PATIENT INVOLVEMENT IS UNKNOWN, HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED.