NEUROFAX

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE EEG TECHNICIAN REPORTED THAT THE ARTIFACT WAS NOT SHOWN CORRECTLY DURING A PROCEDURE AND THE PATIENT HAD NO RESPONSE TO THE STIMULATION WHEN THEY SHOULD HAVE. THEY TRIED USING A DIFFERENT GRASS STIM SYSTEM AND THE PATIENT RESPONDED TO THAT ONE. IT WAS NOTED THERE WAS A DIFFERENCE IN PULSE WIDTH FROM OUR SYSTEM TO THE GRASS SYSTEM. THERE WAS NO PATIENT HARM REPORTED. INVESTIGATION SUMMARY: ADDITIONAL TROUBLESHOOTING WAS PERFORMED BY NK NEUROLOGY ENGINEERING SERVICES, AND THE TROUBLESHOOTING SUGGESTED THAT THE NK MS-120BK DEVICE WAS CAUSING THE ISSUE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER STATED THAT THEY WOULD PURCHASE A NEW MS-120BK DEVICE AND WOULD NOT SEND THE DEVICE FOR REPAIR AS IT IS OUT OF WARRANTY. WITHOUT THE EVALUATION OF THE COMPLAINT UNIT, A DEFINITIVE ROOT COULD NOT BE IDENTIFIED. NK WILL CONTINUE TO MONITOR AND TREND FOR THIS ISSUE. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE EEG-1200AA: STIMULATOR: MODEL #: MS-120BK, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE EEG TECHNICIAN REPORTED THAT THE ARTIFACT WAS NOT SHOWN CORRECTLY DURING A PROCEDURE AND THE PATIENT HAD NO RESPONSE TO THE STIMULATION WHEN THEY SHOULD HAVE. THEY TRIED USING A DIFFERENT GRASS STIM SYSTEM AND THE PATIENT RESPONDED TO THAT ONE. IT WAS NOTED THERE WAS A DIFFERENCE IN PULSE WIDTH FROM OUR SYSTEM TO THE GRASS SYSTEM. THERE WAS NO PATIENT HARD REPORTED.