NEUROFAX
Received Sep 16, 2025 · Event occurred Sep 12, 2025
Report 8030229-2025-05512 · MDR key 23069320
Device
Generic name
Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1260ACatalog number
EEG-1260A
Lot number
NA
Product problems
- Smoking
- Output Problem
- Smoking
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT UPS USED WITH THE EEG STARTED SMOKING WHEN IT WAS POWERED ON. THIS WAS AN OUT OF BOX FAILURE. NO PATIENT HARM 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. POWERVAR UPS. A/ABCE422-11MED. SN NI.
Description of Event or Problem
THE CUSTOMER REPORTED THAT UPS USED WITH THE EEG STARTED SMOKING WHEN IT WAS POWERED ON. THIS WAS AN OUT OF BOX FAILURE. NO PATIENT HARM WAS REPORTED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT UPS USED WITH THE EEG STARTED SMOKING WHEN IT WAS POWERED ON. THIS WAS AN OUT OF BOX FAILURE. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT UPS USED WITH THE EEG STARTED SMOKING WHEN IT WAS POWERED ON. THIS WAS AN OUT OF BOX FAILURE. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE EVALUATION, THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. POWERVAR UPS. A/ABCE422-11MED. SN NI. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.