MalfunctionIPF
ZYNEX
Received Mar 13, 2015 · Event occurred Jun 21, 2014
Report 1723686-2015-00013 · MDR key 4613383
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
ZYNEX: UNIT RETURNED THROUGH FRONT DOOR, BUT NOT AS A QA RETURN. LOW FIRM LETTER ENCLOSED. NO SPECIFICS ON PROBLEM OTHER THAN "PERSONAL INJURY" UNIT WAS TESTED AND FUNCTIONED ACCORDING TO SPEC. NO PROBLEM FOUND. LAW LETTER COULD BE FROM A BILLING PERSPECTIVE AND NOT NECESSARY THE UNIT.
Description of Event or Problem
RECEIVED UNIT WITH LETTER FROM LAW FIRM CLAIMING PATIENT INJURY, BUT NO SPECIFIC AS TO TYPE OF INJURY REPORTED.
Remedial action
- Replace