FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 202
MDR report key: 13425861
·
Received February 2, 2022
Report
- Report Number
- 2518422-2022-02743
- Event Type
- Malfunction
- Date Received
- February 2, 2022
- Date of Event
- January 7, 2022
- Report Date
- February 2, 2022
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- UDI-DI
- 00606959022706
- PMA / PMN Number
- K093905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
COMPONENTS THAT WERE REPLACED DURING SERVICE WERE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. DURING THE EVALUATION OF THE DEVICE'S OXYGEN BLENDING MODULE BOARD AT THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY, FLOW TESTS FAILED DUE TO FAULTY SENSORS U28 AND U29 DUE TO CONTAMINATION. THE COMPONENTS WERE SCRAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296895 | TRILOGY 202 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1040000 | 00606959022706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |