NATUS BRAIN MONITOR BREAKOUT

Additional Manufacturer Narrative

INITIAL REPORT REFERENCE NATUS COMPLAINT# (B)(4). IT WAS CONFIRMED THAT IX DEVICES THAT WERE REWORKED TO NATUS BRAIN MONITOR WERE NOT UPDATED TO INCLUDE THE NATUS BRAIN MONITOR SOFTWARE. THE REWORKED DEVICES WERE TESTED BASED ON IX CRITERIA AND THUS THE ERROR WAS NOT CAUGHT PRIOR TO RELEASE. PER (B)(4) REV 84 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET HAZARD ID 5.132 - CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA EFFECTS (HARM): WRONG DIAGNOSIS LEADING TO COMPLICATIONS. RISK RATING: MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF MEDIUM DUE TO THE NATURE OF THE HAZARD. HAZARDS HAVE ASSOCIATED WARNINGS DISCLOSED IN THE IFU. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. CAPA005799 HAS BEEN GENERATED. THE CORRECTION PLAN IS NOT YET CONFIRMED.

Description of Event or Problem

PART 021911 NATUS BRAIN MONITOR BREAKOUT - THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.

Additional Manufacturer Narrative

FOLLOW UP REPORT REFERENCE NATUS COMPLAINT#: (B)(4). IT WAS CONFIRMED THAT IX DEVICES THAT WERE REWORKED TO NATUS BRAIN MONITOR WERE NOT UPDATED TO INCLUDE THE NATUS BRAIN MONITOR SOFTWARE. THE REWORKED DEVICES WERE TESTED BASED ON IX CRITERIA AND THUS THE ERROR WAS NOT CAUGHT PRIOR TO RELEASE. THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED IN QMS-003367 REV 10 STEP 3 - FUNCTIONAL TEST. DURING THIS STEP, THE FUNCTIONAL TESTER USES THE FIRST SIX DIGITS OF THE SERIAL NUMBER (WHICH REFLECT THE ORIGINAL PART NUMBER) TO IDENTIFY AND LOAD THE APPROPRIATE SOFTWARE FOR THE AMPLIFIER. SINCE THE CONVERTED UNITS RETAINED THE ORIGINAL SERIAL NUMBER STARTING WITH "(B)(6)" (ASSOCIATED WITH THE ORIGINAL BRAIN MONITOR IX), THE SYSTEM INCORRECTLY RECOGNIZED THE DEVICE AS THE ORIGINAL MODEL RATHER THAN THE UPDATED BRAIN MONITOR BREAKOUT (P/N: 021911). AS A RESULT, THE INCORRECT SOFTWARE WAS LOADED, LEADING TO A FALSE PASS RESULT DURING FUNCTIONAL TESTING. CAPA: 005799 WAS GENERATED AND DOCUMENTS THE FOLLOWING: ROOT CAUSE SUMMARY: THERE WAS INSUFFICIENT DILIGENCE IN WRITING AND REVIEW OF THE RE-WORK INSTRUCTIONS. CORRECTIVE ACTION PLAN:AS PART OF RE-WORK PROCESS, SERIAL NUMBERS CANNOT BE MODIFIED. 1. UPDATE QMS-000158 NONCONFORMING PRODUCT PROCEDURE. A). RESPONSIBILITIES SECTION 5.5 ENGINEERING/TECHNICAL AUTHORITY. WHERE TESTING IS REQUIRED, AS PART OF RE-WORK SUSTAINING ENGINEER MUST REVIEW. B). PROCESS FLOWCHARTS 8.0 - INSERT FLOW TO DETERMINE WHETHER ACTIVITIES PERFORMED ARE LIKELY RE-MANUFACTURING. 2. UPDATE WI MM 108. NON-CONFORMING WORK INSTRUCTION. A). 5.0 RESPONSIBILITIES - 5.2.8 ADD VERBIAGE " INCLUDING ANY TESTING." B). 6.0 PROCEDURE - IF THE PART NUMBER THAT IS CONSIDERED NON-CONFORMING REQUIRES A SERIAL NUMBER CHANGE, CEASE AND DO NOT PROCEED WITH ANY RE-WORK ACTIVITIES. 3. QMS-006084. REWORK CONTROL FORM - DESCRIPTION OF REWORK - INSERT (CONFIRM THAT SERIAL NUMBERS WILL NOT CHANGE). FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/SOFTWARE FAILURE.

Description of Event or Problem

PART: 021911 NATUS BRAIN MONITOR BREAKOUT. THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.