VIKING EDX INTERNATIONAL

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT#(B)(4). SERVICE TECHNICIAN SPOKE WITH THE CUSTOMER AND REQUESTED THAT THEY NO LONGER USE THE SYSTEM UNTIL A NATUS FIELD SERVICE TECHNICIAN HAS BEEN ONSITE TO TEST THE SYSTEM. PER INFORMATION RECEIVED: PATIENT INVOLVED :YES. ALLEGED INJURY: YES. ALLEGED DELAY IN TREATMENT: YES. ALLEGED ENVIRONMENTAL OR SAFETY ISSUE: YES. 25-AUGUST-2022: A REQUESTED THAT A ADVERSE EVENT QUESTIONNAIRE BE SENT TO THE CUSTOMER. FURTHER REVIEW OF INVESTIGATION DETAILS TO BE CARRIED OUT.

Description of Event or Problem

VIKING EDX INTERNATIONAL - THE CUSTOMER REPORTS THERE WAS SKIN LESIONS AFTER APPLICATION AND REQUESTED THAT THE DEVICE BE CHECKED FOR ERROR CURRENTS.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4) A NATUS FIELD SERVICE TECHNICIAN VISITED THE CUSTOMER TO CHECK THE SYSTEM. THE SYSTEM WAS CHECKED FOR SAFETY, AND NO ISSUE WAS FOUND. CAPA TRENDING REVIEW: THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED PER (B)(4) EMG-IOM RISK ANALYSIS FILE, HAZARD ID - 10.2, SEVERITY 3 - MARGINAL, THE RISK IS CONSIDERED LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS A DEVICE HISTORY RECORD REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. INSTALL DATE: MARCH 26, 2016. "FAILURE" CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED.

Description of Event or Problem

VIKING EDX INTERNATIONAL - THE CUSTOMER REPORTS THERE WAS SKIN LESIONS AFTER APPLICATION AND REQUESTED THAT THE DEVICE BE CHECKED FOR ERROR CURRENTS.