NEUROFAX

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE POWERVAR UPS THAT WAS BEING USED WITH THE EEG-1260A SYSTEM SPARKED AND SMOKED. THIS 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. NIHON KOHDEN IS NOT THE MANUFACTURER OF THE UPS SO WE DO NOT HAVE THE MANUFACTURED DATE INFORMATION AND NOTED NO INFORMATION (NI), AND NA FOR THE UDI AS IT DOES NOT HAVE A UDI NUMBER. UPS MANUFACTURED BY POWERVAR: MODEL: ABCE422-11MED. SN: (B)(4). DEVICE MANUFACTURE DATE: NI. UNIQUE IDENTIFIER (UDI) #: NA. RETURNED TO NIHON KOHDEN: NO RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE POWERVAR UPS THAT WAS BEING USED WITH THE EEG-1260A SYSTEM SPARKED AND SMOKED. THIS WAS NOT IN PATIENT USE.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNINTERRUPTABLE POWER SUPPLY (UPS) USED WITH THE EEG-1260A SYSTEM SPARKED AND WAS SMOKING. THE DEVICE WAS NOT IN PATIENT USE. INVESTIGATION SUMMARY: AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION, THE REPORTED ISSUE COULD NOT BE DUPLICATED NOR CONFIRMED. AS SUCH, A ROOT CAUSE CANNOT BE DETERMINED. POSSIBLE CAUSES FOR SMOKING AND SPARKING WITH A UPS ARE, 1. OVERLOAD: IF THE CONNECTED DEVICES DRAW MORE POWER THAN THE UPS CAN HANDLE, IT MAY OVERLOAD THE SYSTEM, CAUSING OVERHEATING AND POTENTIAL DAMAGE. 2. SHORT CIRCUIT: A SHORT CIRCUIT WITHIN THE UPS OR IN THE CONNECTED DEVICES CAN LEAD TO EXCESSIVE CURRENT FLOW, RESULTING IN SMOKE AND SPARKS. 3. INTERNAL FAULTS: INTERNAL COMPONENTS OF THE UPS, SUCH AS CAPACITORS, TRANSISTORS, OR OTHER ELECTRONIC PARTS, MAY FAIL DUE TO MANUFACTURING DEFECTS OR WEAR AND TEAR OVER TIME. 4. FAULTY BATTERIES: UPS UNITS OFTEN HAVE BATTERIES TO PROVIDE POWER DURING OUTAGES. IF THESE BATTERIES ARE OLD, DAMAGED, OR MALFUNCTIONING, THEY CAN CAUSE ISSUES, INCLUDING SPARKING AND SMOKING. 5. POWER SURGE: A SUDDEN AND SEVERE INCREASE IN VOLTAGE, EITHER FROM THE UTILITY GRID OR A LIGHTNING STRIKE, CAN OVERWHELM THE UPS AND CAUSE DAMAGE. 6. POOR VENTILATION: INADEQUATE COOLING OR VENTILATION CAN LEAD TO OVERHEATING OF THE UPS COMPONENTS, POTENTIALLY CAUSING SMOKE AND SPARKS. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE EEG SYSTEM AND IS THE DEVICE THAT MALFUNCTIONED. NIHON KOHDEN IS NOT THE MANUFACTURER OF THE UPS. THE MANUFACTURER DATE INFORMATION IS LISTED AS NO INFORMATION (NI). THE UDI INFORMATION IS LISTED AS NO INFORMATION (NI) AS IT DOES NOT HAVE A UDI NUMBER. UPS (MANUFACTURED BY POWERVAR): MODEL: ABCE422-11MED . SN: (B)(6). DEVICE MANUFACTURE DATE: NI. UNIQUE IDENTIFIER (UDI) #: NA. RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNINTERRUPTABLE POWER SUPPLY (UPS) USED WITH THE EEG-1260A SYSTEM SPARKED AND WAS SMOKING. THE DEVICE WAS NOT IN PATIENT USE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNINTERRUPTABLE POWER SUPPLY (UPS) USED WITH THE EEG-1260A SYSTEM SPARKED AND WAS SMOKING. THE 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-1260A 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.