MalfunctionIPF
ZYNEX
Received Mar 13, 2015 · Event occurred Nov 4, 2013
Report 1723686-2015-00010 · MDR key 4613354
Device
Product problems
- Device Emits Odor
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ZYNEX: UNIT WAS TESTED WITH NO PROBLEM FOUND AND PASSED THE FINAL TEST. TESTED FOR DURATION WITH NO BURNED PLASTIC SMELL OR ERRORS OF ANY KIND. THERE IS NO EVIDENCE INTERNALLY OR EXTERNALLY SUGGESTING UNIT EVER GOT HOT OR HAD ANY BURNING PLASTIC SMELL.
Description of Event or Problem
CHANNEL 1 ERROR OCCURS 10-15 MINUTES INTO TREATMENT/BURNED PLASTIC SMELL. HAD PT TEST LW SWITCHED LW THEN RUN UNIT AGAIN. CHANNEL 1 ERROR OCCURRED AFTER LW WERE SWITCHED. PT INDICATES THAT SHE CAN SMELL BURNED PLASTIC. NO HARM TO PT.
Remedial action
- Replace