NATUS BRAIN MONITOR BREAKOUT

Description of Event or Problem

PART 021911 NATUS BRAIN MONITOR BREAKOUT - 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.

Additional Manufacturer Narrative

FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). BRAIN MONITOR UNIT WAS PRODUCT TESTED FOR FUNCTIONALITY AND SAFETY WITH UNIT FOUND OPERATIONAL WITH NO DEFECT. UNITS ARE BEING RETAINED IN ENGINEERING IN THE EVENT A TREND IS FOUND ALLOWING THIS UNIT TO BE FURTHER INSPECTED. PER (B)(4) XLTEK EEG PSG RISK ANALYSIS, HAZARD ID 11.1, SEVERITY 11-CRITICAL, RISK LEVEL-MODERATE. 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. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED.

Description of Event or Problem

PART 021911 NATUS BRAIN MONITOR BREAKOUT - 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). NATUS RECEIVED THE SUSPECT DEVICE BACK. THE REPAIR TECHNICIAN PERFORMED THE EVALUATION AND CONFIRMED THE DEVICE PASSED ALL THE TESTS. THE FOLLOWING WAS NOTED: RAN THE SAFETY TEST PER PROCEDURE QMS-006941 AND IT PASSED ALL TESTS. RAN THE FUNCTIONAL TEST PER PROCEDURE QMS-003367 AND IT PASSED ALL TESTS. THE PRODUCT WAS THEN FORWARDED TO NATUS ENGINEERING FOR FURTHER EVALUATION. CURRENTLY WAITING FOR FEEDBACK. CONFIRMATION WAS RECEIVED ON TYPE OF ELECTRODES USED BY CUSTOMER - ROCHESTER DISPOSABLE GOLD ELECTRODES.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE DEFECTIVE DEVICE WAS REQUESTED TO BE RETURNED TO NATUS FOR EVALUATION. INFORMATION WAS ALSO REQUESTED ON WHAT ELECTRODES WERE USED. 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 DHR 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: (B)(6) 2019. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

PART 021911 NATUS BRAIN MONITOR BREAKOUT. 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.