NEUROCOM EQUITEST

Additional Manufacturer Narrative

A BIOMEDICAL ENGINEERING TECHNOLOGIST (BIOMED) WITH (B)(6) HAS BEEN BROUGHT TO THE USER FACILITY TO DIAGNOSE THE ISSUE AND MAKE REPAIRS AS NECESSARY. NATUS TECHNICAL SERVICE HAS MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE BIOMED TO ASK FOR ADDITIONAL INFORMATION AND AID IN TROUBLESHOOTING THE DEVICE. THE BIOMED WAS MOST RECENTLY IN CONTACT WITH NATUS TECHNICAL SERVICE ON JULY 10, 2018 AND COMMUNICATION IS ONGOING. THE COMPLAINT INVESTIGATION HAS NOT YET REACHED A CONCLUSION REGARDING THE CAUSE OF THE ISSUE.

Description of Event or Problem

NATUS RECEIVED A REPORT THAT A NEUROCOM EQUITEST SYSTEM GENERATED A LARGE, ABNORMAL SWAY MOTION WHILE A UNIVERSITY STUDENT WAS STANDING ON THE FORCE PLATE FOR DEMONSTRATION PURPOSES. THE ABNORMAL MOTION CAUSED A MONITOR MOUNTED IN THE SURROUND TO FALL TO THE FLOOR. FOLLOWING THE ABNORMAL MOTION, THE SYSTEM CEASED FUNCTIONING. NO DEATH OR SERIOUS INJURY OCCURRED, BUT A PROFESSOR (THE COMPLAINANT) SUPERVISING THE STUDENT EXPRESSED CONCERNS THAT THE ABNORMAL SWAY MOTION THE SYSTEM GENERATED COULD CAUSE A PATIENT TO FALL. THE EQUITEST SYSTEM WAS ASSEMBLED IN MAY 2001. PRIOR TO THE EVENT, THE EQUITEST SYSTEM HAD BEEN USED BY THE USER FACILITY FOR CLINICAL ASSESSMENT OF PATIENTS AND FOR TEACHING PURPOSES. NATUS TECHNICAL SERVICE REQUESTED FURTHER INFORMATION REGARDING THE STUDENT AND THE INCIDENT. THE STUDENT DID NOT FALL, BUT THE PROFESSOR WAS STANDING BEHIND THE STUDENT AS A SPOTTER. THE STUDENT WAS NOT WEARING A SAFETY HARNESS. NATUS TECHNICAL SERVICE INFORMED THE COMPLAINANT THAT THE DEVICE DOCUMENTATION STATES THAT TO AVOID INJURY, A PATIENT MUST WEAR A SAFETY HARNESS WHEN USING A DYNAMIC BALANCE SYSTEM. THIS STATEMENT IS FOUND UNDER THE WARNINGS AND PRECAUTIONS SECTION OF THE NEUROCOM BALANCE MANAGER SYSTEMS IFU P/N 005444.

Additional Manufacturer Narrative

NATUS TECHNICAL SERVICE MADE MULTIPLE FOLLOW UP ATTEMPTS WITH CUSTOMER IN ORDER TO TROUBLESHOT THE ISSUE, THE CUSTOMER DID NOT RESPOND TO MULTIPLE FOLLOW-UP COMMUNICATIONS. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED.