EEG-1200A

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE. NO MALFUNCTION OF THE EEG DEVICE WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE.

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: ON (B)(6) 2018, (B)(6) REPORTED THE PTZ CONTROLS WERE OFF THE SCREEN. SERVICE REQUESTED/PERFORMED: INFORMATION WAS PROVIDED TO THE CUSTOMER TO GET THE CONTROLS BACK ONTO THE SCREEN AND RESOLVE THE ISSUE. THERE WAS A REPORT OF A PATIENT DEATH WHILE CONNECTED TO THE MACHINE. THE CUSTOMER WAS CONTACTED MULTIPLE TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT. MISSING INFORMATION: INFORMATION REGARDING THE PATIENT INCIDENT IS MISSING DUE TO LACK OF CUSTOMER RESPONSE. INVESTIGATION RESULT: THE ROOT CAUSE OF THE PTZ ISSUE IS DUE TO USER ERROR/EDUCATION. THE CUSTOMER WAS NOT AWARE OF THE STEPS TO TAKE TO RETURN THE CONTROLS TO THE SCREEN. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS A REPORT OF PATIENT DEATH. HOWEVER, THERE WAS NO INFORMATION TO INDICATE THE PATIENT DEATH WAS DUE TO A DEVICE MALFUNCTION OR DEFICIENCY. THIS DEVICE IS USED FOR DIAGNOSTIC PURPOSES AND NOT MONITORING OF VITAL SIGNS. PER ATTACHED MDR DECISION TREE, THE PTZ ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. BASED ON THE GIVEN INFORMATION, THIS COMPLAINT RECORD CAN BE CONSIDERED LOW RISK AND WILL BE CLOSED AS NO FURTHER INVESTIGATION IS NEEDED AT THIS TIME. CORRECTED INFORMATION: DATE RECEIVED BY MANUFACTURER: SHOULD BE 04/17/2018 NOT 05/16/2018 AS LISTED ON MDR INITIAL REPORT ADDITIONAL INFORMATION: DATE OF THIS REPORT, SERIAL #, HEALTH PROFESSIONAL? OCCUPATION, DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT TYPE OF REPORT, APPROXIMATE AGE OF DEVICE, DATE REPORT SENT TO FDA, DATE REPORT SENT TO MANUFACTURER, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, IF FOLLOW-UP, WHAT TYPE? ADDITIONAL INFORMATION , CORRECTION, DEVICE EVALUATED BY MANUFACTURER? DEVICE MANUFACTURE DATE, EVENT PROBLEM AND EVALUATION CODES, ADDITIONAL MANUFACTURER NARRATIVE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (N/A) TO THIS REPORT: THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: THE CUSTOMER DID NOT INITIALLY RESPOND TO FOLLOW UP REQUESTS. CONTACT WITH THE CUSTOMER WAS FINALLY MADE, HOWEVER, NO INFORMATION WAS PROVIDED. AGE AT TIME OF EVENT, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY, RACE, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS.