MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). NO ASSOCIATED CAPAS. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 0 PREVIOUSLY CONFIRMED "INTEG-PRESSURE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4).1104HMT UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE =(B)(4). RISK MANAGEMENT REVIEW: (IDENTIFY HAZARD ID) A REVIEW OF (B)(4).MEDICAL DEVICE HAZARD ANALYSIS (REV 05), IDENTIFIES THE HAZARD SITUATION AS "12.23 DOES NOT MEASURE INTRACRANIAL PRESSURE ACCURATELY: NON-ROBUST MODULE END ELECTRONICS DESIGN OR MATERIALS / FOR INTENDED USE" BASED ON COMPLAINT OF "PRESSURE NOT READING." THE RISK LEVEL IS CONSIDERED LOW. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY FURTHER INFORMATION REGARDING THE ALLEGED COMPLAINT. FAILURE MODE: NO DEVICE RETURNED - UNABLE TO DETERMINE.

Description of Event or Problem

MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). 07-NOV-2024: NATUS RECEIVED NOTICE OF DISPLAY ISSUE ON CAM02, SN: (B)(6). USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. DEVICE NEEDED TO BE CHANGED, CAUSING A DELAY IN PROCEDURE. THE CATHETER WAS REPLACED. THIS CAMINO SYSTEM CAM02, SN: (B)(6). USED AT THE TIME IS PAST DUE FOR THE YEARLY CALIBRATION ON (B)(6) 2022. FURTHER REVIEW OF COMPLAINT DETAILS TO BE CARRIED OUT.

Description of Event or Problem

MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.