NEUROFAX

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THEIR STAFF BUMPED INTO THE EEG CARD, CAUSING THE CAMERA TO FALL OF THE POLE ONTO THEIR RADIOLOGY STAFF ANKLE. THE CAMERA STILL WORKS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED. 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. ATTEMPT # 1: ON 01/28/2022 EMAILED THE CUSTOMER VIA (B)(6) FOR PATIENT INFORMATION: AN "UNKNOWN" ANSWER WAS RECEIVED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR STAFF BUMPED INTO THE EEG CARD, CAUSING THE CAMERA TO FALL OF THE POLE ONTO THEIR RADIOLOGY STAFF ANKLE. THE CAMERA STILL WORKS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT A STAFF MEMBER BUMPED INTO THE EEG CART, CAUSING THE CAMERA TO FALL FROM THE POLE ONTO THEIR RADIOLOGIST'S ANKLE. THE CAMERA STILL WORKED AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THE SYSTEM WAS CHECKED AND THERE WERE NO LOOSE COMPONENTS. THEY WERE NOT ABLE TO RECREATE HOW THE EVENT OCCURRED. IT WAS REPORTED THAT A STAFF MEMBER BUMPED INTO THE EEG CART WITH RADIOLOGY EQUIPMENT AND THE CAMERA IMPACTED ANOTHER STAFF MEMBER. AS SUCH, THE ROOT CAUSE IS LIKELY RELATED TO USE ERROR AND MISHANDLING. THIS EVENT IS LIKELY AN ISOLATED INCIDENT. THE EEG CART LIKELY MOVED OR TIPPED OVER AS A RESULT OF BEING BUMPED. THERE IS NO EVIDENCE OF AN NK DEVICE MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS AN ATTEMPT TO OBTAIN THE INFORMATION WAS MADE, BUT NOT PROVIDED: A-4 ATTEMPT # 1: 01/28/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED THAT THE INFORMATION WAS UNKNOWN. 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. H10 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A STAFF MEMBER BUMPED INTO THE EEG CART, CAUSING THE CAMERA TO FALL FROM THE POLE ONTO THEIR RADIOLOGIST'S ANKLE. THE CAMERA STILL WORKED AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A STAFF MEMBER BUMPED INTO THE EEG CART, CAUSING THE CAMERA TO FALL FROM THE POLE ONTO THEIR RADIOLOGIST'S ANKLE. THE CAMERA STILL WORKED AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM EEG-1260A TO NEUROFAX. D4 SERIAL NUMBER: CORRECTED THE SERIAL NUMBER FROM (B)(6). 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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?