D
Patient 1
EQUIPMENT INSTALLED 4/2/93. ON 6/29/93 THE SYSTEM STARTED INTERMITTENT LOCK-UPS DURING PT TESTING. TESTS INVOLVED: VTG, RAW. PT DATA LOST. SYSTEM WOULD NOT RESPOND TO WARM RE-BOOTING. SERVICE VISIT. ON 7/6/93: SYSTEM LOCK-UP DURING PT TESTING. SERVICE VISIT. ON 12/7/93: UNIT WILL NOT CALIBRATE. SERVICE CALL. ON 12/14/93: SYSTEM LOCK-UP RAW. ON 12/17/93: SYSTEM LOCK-UP RAW. SERVICE VISIT. THIS INFORMATION WAS SUBMITTED AS FOLLOW-UP 4/20/94: ON 2/8/94: SYSTEM LOCK-UP DURING COMPLIANCE STUDY DEMONSTRATION BY CO CLINICAL SPECIALIST. ON 2/9/94: SERVICE VISIT. ON 3/2/94: SYSTEM LOCK-UP DURING RAW. COMPANY CALLED; NO ACTION TAKEN. ON 3/21/94: SYSTEM LOCK-UP DURING RAW. NO FLOW VOLUME LOOPS PRINTED ON PT REPORTS. DISAPPEARANCE OF DATA FROM HARD DRIVE. ON 3/23/94: SYSTEM REMOVED FROM PT TESTING. ON 3/24/94: SERVICE VISIT. ACTION WAS TO RECOMMEND "ADDITIONAL TRAINING" THREE TECHNOLOGISTS AS A SOLUTION FOR THE SYSTEM LOCK-UPS. QUESTION: DOES THIS "ADDITIONAL TRAINING" IMPLY INCOMPETENCE ON THE PART OF THE THREE TECHNOLOGISTS (INCLUDING THE REPORT FILER), SUCH THAT THE MED-WATCH WAS FILED BY A PERSON DEEMED INCOMPETENT AT THE TIME OF FILING." THIS INFO WAS SUBMITTED AS FOLLOW UP 9/29/94: 6/30/94: SERVICE VISIT FOR OTHER EQUIPMENT FAILURE. INCIDENTAL SOFTWARE UPGRADE BY SERVICE TECH ON PLETHYSMOGRAPH. PLETHYSMOGRAPH REMAINS CLOSED TO PT TESTING. 7/9/94: COMPLETE TEST PERFORMED WITH LAB TECHNOLOGIST AS SUBJECT WITHOUT INCIDENT. RAW REPEATED: REMOVE BUTTON PRESSED AND HELD TO COLLECT RAW LOOPS. SHUTTER CLOSED IMMEDIATELY AND STAYED CLOSED, CUTTING OFF AIR TO THE SUBJECT. BUTTON RELEASED; SUBJECT COULD NOT BREATHE. UNIT NOT SHIFT INTO VTG MODE (AS SETUP IN PROTOCOL SCREEN). VIDEO SCREEN FROZE IN RAW MODE. THIS IS THE FIRST TIME THIS EQUIPMENT FAILED WITH A LABORATORY TECHNOLOGIST AS THE SUBJECT. PREVIOUS ATTEMPTS TO REPLICATE THESE FAILURE WERE UNSUCCESSFUL. ON 7/15/94 COMPANY CALLED. PLETHYSMOGRAPH REMAINS CLOSED TO PT TESTING.