Description of Event or Problem · 0
A TRILOGY 100 VENTILATOR, U.S.A - BT DEVICE WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE/ FLOW PATH REPLACEMENT. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE FLOW PATH REPLACEMENT AT THE MANUFACTURER'S SERVICE CENTER, THE ACTIVE EXHALATION CONTROL MODULE (AECM) WAS DAMAGED DUE TO ASSEMBLER ERROR. THE AECM WAS REPLACED DUE TO PHYSICAL DAMAGE. THE DEVICE FAILED TO COMMUNICATE WITH THE TEST STATION. THE DEVICE COMMUNICATED WITH TRILOGY TOOLBOX BUT WOULD NOT COMMUNICATE WITH THE TEST STATION. AFTER INVESTIGATION, FOUND DEVICE HAS AN ISSUE WITH THE CPLD CHIP ON THE SYSTEM BOARD. THE SYSTEM BOARD HAS BEEN REPLACED DUE TO CPLD CHIP AND COMMUNICATION ISSUE. DEVICE OPERATES AS IT SHOULD - SENT DEVICE TO RUN IN AND IS AWAITING TESTING. IT WAS UPON FINAL TESTING OF THE DEVICE, THAT IT CAME TO FAIL FOR THE NURSE CALL TEST. PENDING CUSTOMER APPROVAL, THE DEVICE'S INTERFACE BOARD WILL NEED TO BE REPLACED TO ADDRESS THIS PROTECTIVE MEASURE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.