COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)

Additional Manufacturer Narrative

FOLLOW UP 001 REF NATUS COMPLAINT# (B)(4). SEVERAL REQUESTS WERE MADE TO CONFIRM IF PRODUCT WOULD BE RETURNED. 21-NOV-2022: CUSTOMER DID NOT RETURN THE PRODUCT. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 58 CONFIRMED COMPLAINTS, GIVING AN INCIDENT RATE OF (B)(4). 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. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 5.10 (B)(4) CAMINO ICP MONITOR RISK ANALYSIS, CONSIDERED TO BE A MODERATE RISK. DEVICE HISTORY RECORD WAS REVIEWED, UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING OR MATERIAL DEFECTS, NO NON-CONFORMANCES OBSERVED. INSTALL DATE: 30-MAY-2020. FAILLURE CONFIRMED: NO. INVESTIGATION RESULT CODE: SAN DIEGO/EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED AS THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT. THIS COMPLAINT WILL CLOSE, IF THE CUSTOMER DECIDES TO RETURN THE DEVICE THEN ANOTHER COMPLAINT WILL BE GENERATED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. BASED ON EVALUATION OF THIS COMPLAINT THERE IS NO SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

Description of Event or Problem

PART CAM02: NO CATHETER DETECTED. THE CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT. WAITING ON FURTHER FEEDBACK FROM THE CUSTOMER AND TO CONFIRM IF THE PART WILL BE RETURNED FOR INVESTIGATION.

Description of Event or Problem

PART CAM02 - NO CATHETER DETECTED. THE CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT. WAITING ON FURTHER FEEDBACK FROM THE CUSTOMER AND TO CONFIRM IF THE PART WILL BE RETURNED FOR INVESTIGATION.

Additional Manufacturer Narrative

23-SEP-2022: SIEBEL/SALESFORCE SHOWS CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. CUSTOMER ASKED TO RETURN THE COMPLAINT FORM. CATHETER WAS REMOVED FROM THE PATIENT. 26-SEP-2022: SECOND REQUEST MADE FOR RETURN OF COMPLAINT FORM, ALSO ASKED FOR INFORMATION ON CATHETER. 03-OCT-2022: THIRD ATTEMPT MADE TO COLLECT COMPLAINT FORM. FURTHER INVESTIGATION TO BE CARRIED OUT.