BIS ADVANCE
Received Nov 20, 2024
Report 2936999-2024-01811 · MDR key 20737343
Device
Generic name
Reduced- Montage Standard Electroencephalograph
Manufacturer
Jabil Circuit Singapore Pte LtdModel number
PMB4000CEIFU-WECatalog number
PMB4000CEIFU-WE
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ACCORDING TO THE REPORTER, THE PRODUCT'S NUMERIC VALUES WERE NOT CORRECT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.