MalfunctionIPF
ZYNEX
Received Mar 18, 2015 · Event occurred Oct 24, 2013
Report 1723686-2015-00014 · MDR key 4617676
Device
Product problems
- Device Emits Odor
- Overheating of Device
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UNIT GOT HOT AND STARTED TO SMELL LIKE SULPHER AND BURNING SMELL. THEN THE UNIT SHUT OFF AND DOESN'T TURN ON AT ALL.
Additional Manufacturer Narrative
ZYNEX: NO UNUSUAL INDICATIONS FROM EXTERIOR INSPECTION. INTERNAL INSPECTION REVEALS THAT F1 SHOWS SIGNS OF DISCOLORATION. F1, Q27 AND Q28 BAD. ANY COMPONENTS THAT AREN'T FUNCTIONING PROPERLY WOULD GIVE OFF A BURNING SMELL. COMPLAINT CONFIRMED. NO HARM TO PATIENT.