FDA Adverse Event
Malfunction
Summary report: N
TRILOGY EVO
MDR report key: 18685286
·
Received February 12, 2024
Report
- Report Number
- 2518422-2024-06839
- Event Type
- Malfunction
- Date Received
- February 12, 2024
- Date of Event
- December 4, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959051942
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER..
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE IS REQUIRED. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER THE TOUCHSCREEN VERIFICATION TEST FAILED. THE FAILURE WAS CAUSED BY THE FLEX CABLE BEING DISCONNECTED. CONTAMINATION WAS FOUND INSIDE THE DEVICE AND THE FOLLOWING PARTS WERE REPLACED, TRILOGY EVO TUBING PART NUMBERS, 1140098, 1140100, 1140101, 1135260, AND THE TRILOGY EVO AIR INLET FOAM. ADDITIONALLY THE RETURN TUBING, SENSOR CABLE, AND SENSOR/KAPTON TAPE WERE REPLACED. THE DEVICE PASSED ALL INSPECTIONS AND TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1298886 | TRILOGY EVO | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | DS2110X11B | 00606959051942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |