ZYNEX
Received Feb 10, 2012 · Event occurred Jan 18, 2012
Report 1723686-2012-00001 · MDR key 2453685
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Shock
Narrative
Description of Event or Problem
PT REPORTED THAT SHE RECEIVED A SHOCK AND A BLISTER ON HER SKIN.
Additional Manufacturer Narrative
INVESTIGATION: DHR REVIEW REVEALED THAT THE UNIT WAS MFG BY ZYNEX ON (B)(4) 2011, WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE: IFC, LOW-HIGH; TIMER: 60 MIN., DATA: 1112 MINS, 29 TIMES. UNIT TESTED AND INSPECTED BY (B)(6), ON (B)(4) 2012. OSCILLOSCOPE TEST PERFORMED IN ALL MODES. ALL WAVEFORM LEVELS AND TIMINGS WERE CORRECT AND ACCORDING TO SPECIFICATION. ON-SKIN TEST PERFORMED. ELECTRODES CONNECTED TO UNDERSIDE OF RIGHT FOREARM. TESTED IN LOW-HIGH MODE AT 8 MA OUTPUT. BATTERY POWERED USING PARTIALLY DRAINED ZYNEX BATTERY. WHILE TREATMENT WAS IN EFFECT, TOUCHED CENTER CONDUCTOR OF AC ADAPTER INPUT CONNECTOR. WAS NOT ABLE TO REPLICATE THE PROBLEM. NO SHOCKING SENSATION OCCURRED WHILE PROBING AROUND THE AC ADAPTOR CONNECTOR. CONCLUSION: IT IS INCONCLUSIVE EXACTLY HOW THE PT EXPERIENCED A SHOCKING SENSATION.
Remedial action
- Replace