TRILOGY EV300, USA
Report
- Report Number
- 2518422-2025-105818
- Event Type
- Malfunction
- Date Received
- May 19, 2025
- Date of Event
- May 14, 2025
- Report Date
- November 5, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959052017
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
PREVIOUSLY REPORTED BY THE MANUFACTURER: PREVIOUSLY REPORT TO THE MANUFACTURER: A TRILOGY EV300 WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE UNIT FAILED PRE-TESTING, UNIT FAILED SYSTEM SETUP TEST (ACTIVE EXHALATION VERIFICATION: S(+) P(+): PILOT: READING FAILED). THE TECHNICIAN RECOMMENDED REPLACING THE TRILOGY EVO 3-WAY SOLENOID, PROPORTIONAL VALVE (AECM) AND OXYGEN BLENDING MODULE (OBM) TO ADDRESS THE ISSUE. THE REPAIRS ARE PENDING THE CUSTOMERS APPROVAL. FCO FOLLOW-UP REPAIR TO BE HANDLED BY CARROT MEDICAL. A SUPPLEMENT REPORT WILL BE FILED IF NEW INFORMATION BECOMES AVAILABLE. INFORMATION REPORTED IN DUPLICATE RA 320523417 PR 773045. A TRILOGY EV300 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, AFTER REPLACING THE PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE, THE UNIT FAILED THE SENSOR DRIFT VERIFICATION TEST. THIS WAS NOT AN INITIAL FAILURE AND OCCURRED AFTER REPAIRS WERE PERFORMED ON THE DEVICE. PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE WERE REPLACED, ALONG WITH THE FLOW SENSOR AS PART OF FCO8. EV300 SYSTEM BOARD WAS REPLACED TO ADDRESS THE SENSOR DRIFT VERIFICATION TEST FAILURE. PREVIOUSLY REPORTED: THE FAILED PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE WERE RECEIVED AT THE PHILIPS PRODUCT INVESTIGATION LAB FOR FURTHER INVESTIGATION. ERROR CODES WERE NOTED IN THE EVENT LOG. BOX H CODING WAS UPDATED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. NEW INFORMATION/LINV: THE PROPORTIONAL VALVE AND SOLENOID VALVE WERE RETURNED TO RIQL FOR AN ACTIVE EXHALATION VERIFICATION TEST FAILURE AT SERVICE. THIS FAILURE IS BEING FURTHER INVESTIGATED BY THE MANUFACTURER. NO FURTHER EVALUATION OF THIS PART IS REQUIRED AT THIS TIME. THE TUBING WAS RETURNED TO RIQL FOR THE FAILURE OF A SENSOR DRIFT OR AECM TEST FAILURE AT SERVICE. THE TUBING WOULD ONLY FAIL DUE TO PHYSICAL DAMAGE OR CLOGGING DUE TO CONTAMINATION. NO FURTHER INVESTIGATION OF THE TUBING IS REQUIRED AT THIS TIME. THE TRILOGY EVO SYSTEM BOARD WAS RETURNED TO RIQL WITH THE ALLEGATION OF A SENSOR DRIFT TEST FAILURE AT SERVICE. THE PRODUCT INVESTIGATION LAB (PIL) WAS ABLE TO CONFIRM A FAILURE OF THE SYSTEM BOARD. THE PRODUCT INVESTIGATION LAB (PIL) VISUALLY INSPECTED THE TRILOGY EVO SYSTEM BOARD FOR VISUAL DEFECTS AND FOUND THAT THE MT7 SENSOR MAY HAVE BEEN PREVIOUSLY DAMAGED AND APPEARS TO HAVE BEEN ALTERED WITH SOME TYPE OF ADHESIVE. PIL SUSPECTS THAT THE TAMPERING OF THE SENSOR CAUSED THE SENSOR DRIFT FAILURE AT SERVICE. THE TRILOGY EVO SYSTEM PCA HAS BEEN SCRAPPED.
PREVIOUSLY REPORT TO THE MANUFACTURER: A TRILOGY EV300 WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE UNIT FAILED PRE-TESTING, UNIT FAILED SYSTEM SETUP TEST (ACTIVE EXHALATION VERIFICATION: S(+) P(+): PILOT: READING FAILED). THE TECHNICIAN RECOMMENDED REPLACING THE TRILOGY EVO 3-WAY SOLENOID, PROPORTIONAL VALVE (AECM) AND OXYGEN BLENDING MODULE (OBM) TO ADDRESS THE ISSUE. THE REPAIRS ARE PENDING THE CUSTOMERS APPROVAL. FCO FOLLOW-UP REPAIR TO BE HANDLED BY CARROT MEDICAL. A SUPPLEMENT REPORT WILL BE FILED IF NEW INFORMATION BECOMES AVAILABLE. INFORMATION REPORTED IN DUPLICATE RA 320523417 PR 773045. A TRILOGY EV300 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, AFTER REPLACING THE PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE, THE UNIT FAILED THE SENSOR DRIFT VERIFICATION TEST. THIS WAS NOT AN INITIAL FAILURE AND OCCURRED AFTER REPAIRS WERE PERFORMED ON THE DEVICE. PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE WERE REPLACED, ALONG WITH THE FLOW SENSOR AS PART OF FCO8. EV300 SYSTEM BOARD WAS REPLACED TO ADDRESS THE SENSOR DRIFT VERIFICATION TEST FAILURE. NEW INFORMATION: THE FAILED PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE WERE RECEIVED AT THE PHILIPS PRODUCT INVESTIGATION LAB FOR FURTHER INVESTIGATION. ERROR CODES WERE NOTED IN THE EVENT LOG. BOX H CODING WAS UPDATED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
A TRILOGY EV300 WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE UNIT FAILED PRE-TESTING, UNIT FAILED SYSTEM SETUP TEST (ACTIVE EXHALATION VERIFICATION: S(+) P(+): PILOT: READING FAILED). THE TECHNICIAN RECOMMENDED REPLACING THE TRILOGY EVO 3-WAY SOLENOID, PROPORTIONAL VALVE (AECM) AND OXYGEN BLENDING MODULE (OBM) TO ADDRESS THE ISSUE. THE REPAIRS ARE PENDING THE CUSTOMERS APPROVAL. FCO FOLLOW-UP REPAIR TO BE HANDLED BY CARROT MEDICAL. A SUPPLEMENT REPORT WILL BE FILED IF NEW INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136208 | TRILOGY EV300, USA | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | DS2200X11B | 00606959052017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |