MalfunctionIRQ
RICHMAR
Received Jul 16, 2021
Report 3012316249-2021-00023 · MDR key 12182363
Device
Product problems
- Fire
- Fire
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HEATING ELEMENT WAS REPLACED 6 WEEKS AGO AND HAVE WORKED FINE SINCE THEN. LAST NIGHT SOMEONE WAS WALKING BY THE AREA AND SMELLED PLASTIC. THE UNIT WAS REPORTEDLY ON FIRE, A FIRE EXTINGUISHER WAS USED, THE ONSITE BIOMED DID A QUICK EVALUATION AND BELIEVES THAT THE FIRE STARTED FROM THE RECENTLY REPLACED HEATING ELEMENT. CONNECTORS TO THE HEATER ARE STILL GOOD. IT DEFINITELY APPEARS THAT THE HEATER (OR WIRES) SHORTED, NOT THE POWER SUPPLY. FUSE DID NOT BLOW.
Remedial action
- Inspection