NEUROFAX

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT BACK IN 11/2021, IT WAS REPORTED TO THEM THAT THE IR (INFRA RED) ILLUMINATOR SPARKED AND GAVE OFF SOME SMOKE. THE SYSTEM WAS TURNED OFF IMMEDIATELY, AND THEY DETERMINED IT WAS THE IR ILLUMINATOR. THEY CONTINUED TO USE THE EEG SYSTEM WITHOUT USING THE ILLUMINATOR UNTIL NOW. HOWEVER, ONE OF THE DOCTORS NEEDS IT WORKING. THIS IS NOT AN ISSUE WITH THE EEG ITSELF BUT WITH THE THIRD PARTY IR ILLUMINATOR MANUFACTURED BY BOSCH. THIS DEVICE WAS NOT IN PATIENT USE. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE EEG. BOSCH IR ILLUMINATOR, THIRD PARTY DEVICE MODEL: IIR-50850-SR. SN: (B)(4).

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT BACK IN 11/2021, IT WAS REPORTED TO THEM THAT THE IR (INFRA RED) ILLUMINATOR SPARKED AND GAVE OFF SOME SMOKE. THE SYSTEM WAS TURNED OFF IMMEDIATELY, AND THEY DETERMINED IT WAS THE IR ILLUMINATOR. THEY CONTINUED TO USE THE EEG SYSTEM WITHOUT USING THE ILLUMINATOR UNTIL NOW. HOWEVER, ONE OF THE DOCTORS NEEDS IT WORKING. THIS IS NOT AN ISSUE WITH THE EEG ITSELF BUT WITH THE THIRD PARTY IR ILLUMINATOR MANUFACTURED BY BOSCH. THIS DEVICE WAS NOT IN PATIENT USE.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE IR (INFRARED) ILLUMINATOR ON THE EEG SYSTEM SPARKED AND WAS SMOKING. THE DEVICE WAS NOT IN PATIENT USE. INVESTIGATION SUMMARY: FURTHER INVESTIGATION IS DOCUMENTED UNDER CAPA 2023-001. THE CAPA FINDINGS WERE THAT THE EARLY FAILURES OF THE A/IIR-50850-SR WERE CAUSED BY THE FAILURE OF AN INTERNAL COMPONENT WHICH WOULD RESULT IN POSSIBLE SMOKE, SPARKS, AND BURNING SMELLS. THE ROOT CAUSE WAS PRESUMED TO BE RELATED TO IMPROPER INSTALLATION BY NK INSTALLERS PER THE INVESTIGATION BY THE MANUFACTURER, BOSCH. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME AS NKA INSTALLATION PROCEDURES DO NOT SUPPORT THE CLAIM THAT THE ROOT CAUSE WAS RELATED TO AN INSTALLATION ERROR. THE A/IIR-50850-SR WAS THEN DISCONTINUED FOR SALE BY NKA AND WAS REPLACED WITH A DIFFERENT BRAND OF IR ILLUMINATOR. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE, WHICH IS THE DEVICE THAT EXPERIENCED THE FAILURE, WAS USED IN CONJUNCTION WITH THE EEG: BOSCH IR ILLUMINATOR (THIRD-PARTY DEVICE), MODEL: IIR-50850-SR. SN: (B)(6).

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE IR (INFRARED) ILLUMINATOR ON THE EEG SYSTEM SPARKED AND WAS SMOKING. THIS DEVICE WAS NOT IN PATIENT USE.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES** CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM EEG-1200A TO NEUROFAX. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE IR (INFRARED) ILLUMINATOR ON THE EEG SYSTEM SPARKED AND WAS SMOKING. THIS DEVICE WAS NOT IN PATIENT USE.