NATUS PHOTIC STIM KIT

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). INSTALL DATE OF DEVICE : SEP/30/2022 FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

NATUS PHOTIC STIM KIT - EEG TECH WAS ADJUSTING LIGHT WHEN HER SKIN GOT PINCHED BETWEEN THE TWO ARMS OF EQUIPMENT. 30 MINUTES IN THE ED GETTING FINGER STITCHED UP.

Description of Event or Problem

NATUS PHOTIC STIM KIT - EEG TECH WAS ADJUSTING LIGHT WHEN HER SKIN GOT PINCHED BETWEEN THE TWO ARMS OF EQUIPMENT. 30 MINUTES IN THE ED GETTING FINGER STITCHED UP.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). REF. XLTEK PHOTIC STIMULATOR ON A ROLL STAND. REF. 10440 SERIAL NUMBER (B)(6). PER (B)(4) REV 78 EEG/PSG RISK ANALYSIS: HAZARD 6.1 - SHARP CORNER, EDGES OR PINCH POINTS. EFFECT (HARM): BRUISE / CONTUSION OR ABRASION RBA RATING: LOW. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018 (RISK MANAGEMENT SYSTEM PROCEDURE), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. AS PER THE CUSTOMERS RESPONSE, THE CUSTOMER WILL NOT RETURN THE AFFECTED DEVICE FOR EVALUATION. BECAUSE THE CUSTOMER IS NOT ABLE TO RETURN THE DEVICE, NO FURTHER INVESTIGATION CAN BE MADE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.