NEUROWORKS 8.X ACQUISITION SOFTWARE WITH SPIKE / EVENT AND HIGH RES VIDEO

Description of Event or Problem

NEUROWORKS, NON-NORMALIZING QUANTITATIVE ELECTROENCEPHALOGRAPH SOFTWARE - THE CUSTOMER REPORTED THAT THE CREDENTIALS BEING USED ARE EASILY GUESSABLE AND CAN BE FOUND ON THE INTERNET.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). WE WERE NOTIFIED OF RELATED REPORT# MW5154751, AND A INVESTIGATION WILL BE CARRIED OUT. CUSTOMER DOES NOT BELIEVE CONFIGURATIONS ARE VALIDATED AND CONCERNED, "CREDENTIALS BEING USED ARE EASILY GUESSABLE AND CAN BE FOUND ON THE INTERNET."

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). PER (B)(4) RISK ANALYSIS SPREADSHEET: HAZARD 12.6 INCORRECT COMPONENTS, OR COMPONENT SPECIFICATIONS, RECEIVED IN AND USED DURING PRODUCT ASSEMBLY. EFFECTS (HARM): DELAY IN USE OF THE SYSTEM WITH NO CLINICAL EFFECTS. THE HAZARDS IDENTIFIED HAVE RBA RATING OF NEGLIGIBLE AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. TPI-4218 REPORT ADDRESSED THIS ISSUE ALONG WITH DEFECT NW-25299. CUSTOMER WAS PROVIDED WITH A CUSTOM PASSWORD CONFIGURATION AS A RESOLUTION. REPORT STATES, "CUSTOMER IS WORKING WITH SERVICE TEAM TO IMPLEMENT THIS LOCAL SQL(STRUCTURED QUERY LANGUAGE) CUSTOM PASSWORD CONFIGURATION. CUSTOMER IS CURRENTLY TESTING CUSTOM PASSWORD SOLUTION WITH CREDENTIALS CACHE IN THEIR TEST ENVIRONMENT." REPORT WAS CLOSED WITH THE RESOLUTION, 'TPI RESOLVED BY PROVIDING EDUCATION OR INFORMATION.' FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NO ISSUES NOTED.

Description of Event or Problem

NEUROWORKS, NON-NORMALIZING QUANTITATIVE ELECTROENCEPHALOGRAPH SOFTWARE - THE CUSTOMER REPORTED THAT THE CREDENTIALS BEING USED ARE EASILY GUESSABLE AND CAN BE FOUND ON THE INTERNET.