OBM NEONATAL HYDROGEL SENSORS

Description of Event or Problem

OLYMPIC BRAINZ MONITOR OBM NEONATAL HYDROGEL SENSORS - GEL TAB SENSOR ISSUE. PATIENT PRESENTED DAMAGE TO THE SKIN ON THEIR HEAD. THE CUSTOMER STATED: A LESION WAS INVESTIGATED USING A D PARIETAL BRAINZ ELECTRODE, MEASURING 0.5 X 0.5 CM, WITH LOSS OF SKIN INTEGRITY, SCANT SEROUS EXUDATE, NO SIGNS OF INFECTION, SURROUNDING SKIN UNDAMAGED, SKIN WARM TO THE TOUCH. EVENT (B)(6).

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION AND REQUESTED PHOTOS OF THE INJURIES WERE NOT RECEIVED. ADDITIONAL REVIEW OF COMPLAINT DETAILS CONFIRMS THAT OBM HYDROGEL SENSORS WOULD NOT CAUSE ANY BLISTERS TO THE SKIN, INCONVENIENCE WOULD BE CAUSED BY THE SKIN PREP. THE CUSTOMER STATED THEY WILL TAKE FURTHER STEPS TOWARDS RESOLVING THE ISSUE THROUGH TRAINING FOR MEDICAL STAFF. INVESTIGATION RESULT CODE: NEURO SBU/USER ERROR.

Description of Event or Problem

OLYMPIC BRAINZ MONITOR OBM NEONATAL HYDROGEL SENSORS - GEL TAB SENSOR ISSUE. PATIENT PRESENTED DAMAGE TO THE SKIN ON THEIR HEAD. THE CUSTOMER STATED: A LESION WAS INVESTIGATED USING A D PARIETAL BRAINZ ELECTRODE, MEASURING 0.5 X 0.5 CM, WITH LOSS OF SKIN INTEGRITY, SCANT SEROUS EXUDATE, NO SIGNS OF INFECTION, SURROUNDING SKIN UNDAMAGED, SKIN WARM TO THE TOUCH. EVENT 1/2.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). PER OBM RISK ANALYSIS SPREADSHEET DOC-013950 REV 13 HAZARD 9.1 - ELECTRODES BECOME HOT CAUSING BURNS TO PATIENT. EFFECT (HARM): FIRST DEGREE BURNS. RESIDUAL RISK: LOW. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, 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. THE CUSTOMER RETURNED THE AE QUESTIONNAIRE. PER QUESTIONNAIRE, THE CUSTOMER REPORTED THE PROCESS OF CLEANING THE AREA FOR THE ELECTRODES AND THAT THE PATIENT SHAVES, CLEANS WITH PHYSIOLOGICAL SERUM AND DRIES IT. THEY APPLY THE SKIN PROTECTOR SPRAY, NUPREP AND THEN INSTALL THE SENSOR WITH CONDUCTING PASTE. THE CUSTOMER ALSO REPORTED THEY USE THE TEN PASTE AND CAN'T RETURN THE DEFECTIVE PART. FURTHER INVESTIGATION TO BE CARRIED OUT.