OBM DAB (DIGITAL ACQUISITION BOX)

Additional Manufacturer Narrative

FOLLOW UP REPORT# 002 REF NATUS COMPLAINT# (B)(4). PRODUCT EXAMINATION AND FUNCTIONAL TESTING: THE EBS INVESTIGATION NOTES ARE AS FOLLOWS: EVALUATED THE FUNCTION OF CUSTOMERS OBM00002 SERIAL # (B)(4). DAP USING A DEPOT REPAIR STOCKED OBM00401R. RAN COMPLETE FUNCTION TEST PER DOCUMENT (B)(4). ASSEMBLY FUNCTIONAL TEST. WHILE TESTING CUSTOMERS DAP, PERFORMED MULTIPLE WIRE PULLS, TWISTS ON USB CABLE SIDE OF DAP WITH NO FAULTS DURING TESTING. PERFORMED COMPLETE EVALUATION OF CUSTOMERS OBM00401 SERIAL NUMBER (B)(4). WITH DEPOT REPAIR GOLDEN DAP UNIT PER DOCUMENT (B)(4).. DUT PASSED ALL TESTS. FURTHER EVALUATION CONSISTED OF USING BOTH CUSTOMERS OBM AND DAP FOR COMPLETE FUNCTION TESTS PER DOCUMENT (B)(4). WITH A 14 HOUR BURN IN. DURING TESTING AND CHECKING ALERT FUNCTION WHEN DAP IS UNPLUGGED NOTICED NO AUDIBLE ALERT SOUNDING. FOUND THE SOUND FUNCTION HAS BEEN MUTED IN THE OBM. RESET SOUND AND AUDIBLE ALERT WAS ACTIVE, AS IT SHOULD. COULD NOT DUPLICATE CUSTOMER CONCERN WITH DAP FAILING SELF-CHECK. AFTER INITIAL EVALUATION OF OBM00401 PERFORMED REIMAGE AND SOFTWARE RELOAD OF PC, PERFORMED ONE LAST FUNCTION TEST USING CUSTOMER DAP. PASSED ALL TESTS. INSTALL DATE: APR-09-2021. FAILLURE CONFIRMED: NO. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

Description of Event or Problem

PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) - OBM DAB (DIGITAL ACQUISITION BOX) - THE CUSTOMER REPORTED A SIGNAL, "FAILED SELF CHECK." PER QUESTIONNAIRE, THE MEDICAL TEAM WERE WORKING WITH A BABY WHEN THE OBM SIGNALED "FAILED SELF CHECK" FOR 20 -30 MINUTES. THE REGISTERED NURSE TRIED TO TROUBLESHOOT, INCLUDING CHANGING TO A DIFFERENT USB. THE OBM UNIT FINALLY WORKED AFTER 7-8 ATTEMPTS BUT THEY WERE UNCLEAR WHAT MADE THE DIFFERENCE.

Additional Manufacturer Narrative

FOLLOW UP REPORT# 001 REF NATUS COMPLAINT# (B)(4). THE CUSTOMER WAS REQUESTED TO RETURN THE DEFECTIVE UNIT. THE CUSTOMER RESPONDED THAT HOSPITAL POLICY REGARDING MEDICAL DEVICE ADVERSE EVENTS IS TO INVESTIGATE THE DEVICE INTERNALLY AND THEN WILL DECIDE WHETHER IT NEEDS TO BE RETURNED TO THE VENDOR. CASE (B)(4) WAS SET UP TO SEND A LOANER UNIT (SN (B)(6)) AND FOR THE RETURN OF THE DEFECTIVE UNIT. THE CUSTOMER EMAILED AND ASK FOR THE REASON FOR THE FAILURE. SERVICE RESPONDED AND SAID THEY DO NOT KNOW THE ROOT CAUSE OF THE FAILURE, AND THAT THE "THE SELF-CHECK VERIFIES THAT THE DAB IS CORRECTLY CALIBRATED AND READY TO MEASURE ALL THREE CHANNELS OF EEG AS WELL AS THE IMPEDANCE FOR EACH OF THE P3, C3, P4 AND C4 ELECTRODES." THEY ALSO REQUESTED FOR THE CUSTOMER TO RETURN THE SYSTEM AFTER THEIR INTERNAL INVESTIGATION. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. 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. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) - OBM DAB (DIGITAL ACQUISITION BOX) - THE CUSTOMER REPORTED A SIGNAL, "FAILED SELF CHECK." PER QUESTIONNAIRE, THE MEDICAL TEAM WERE WORKING WITH A BABY WHEN THE OBM SIGNALED "FAILED SELF CHECK" FOR 20 -30 MINUTES. THE REGISTERED NURSE TRIED TO TROUBLESHOOT, INCLUDING CHANGING TO A DIFFERENT USB. THE OBM UNIT FINALLY WORKED AFTER 7-8 ATTEMPTS BUT THEY WERE UNCLEAR WHAT MADE THE DIFFERENCE.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). WHEN RESPONDING TO WHETHER THE PATIENT REQUIRED FURTHER HOSPITALIZATION, THE CUSTOMER RESPONDED "YES," AND THAT THE BABY HAD "SEVERE NEONATAL ASPHYXIA AND TRANSFERRED TO GENERAL HOSPITAL FOR THERAPEUTIC HYPOTHERMIA AND SEIZURES." ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER HAZARD ID LINE 5.6 IN DOC-013950 OLYMPIC BRAINZ MONITOR RISK ANALYSIS SPREADSHEET, SEVERITY 3. THE RISK IS CONSIDERED LOW. INSTALL DATE: (B)(6). FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) - OBM DAB (DIGITAL ACQUISITION BOX) - THE CUSTOMER REPORTED A SIGNAL, "FAILED SELF CHECK." PER QUESTIONNAIRE, THE MEDICAL TEAM WERE WORKING WITH A BABY WHEN THE OBM SIGNALED "FAILED SELF CHECK" FOR 20 -30 MINUTES. THE REGISTERED NURSE TRIED TO TROUBLESHOOT, INCLUDING CHANGING TO A DIFFERENT USB. THE OBM UNIT FINALLY WORKED AFTER 7-8 ATTEMPTS BUT THEY WERE UNCLEAR WHAT MADE THE DIFFERENCE.