[8315]
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.
Patient Sequence No: 1, Text Type: D, B5