FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 200
MDR report key: 10425632
·
Received August 19, 2020
Report
- Report Number
- 2518422-2020-01947
- Event Type
- Malfunction
- Date Received
- August 19, 2020
- Date of Event
- July 28, 2020
- Report Date
- July 28, 2020
- Manufacturer
- RESPIRONICS INC
- Product Code
- CBK
- PMA / PMN Number
- K093416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IT WAS PREVIOUSLY REPORTED IN SECTION D1 THAT THE DEVICE IS A TRILOGY 202.SECTION D1 HAS BEEN AMENDED TO REFLECT THE DEVICE IS A TRILOGY 200. IT WAS PREVIOUSLY REPORTED IN SECTION G5 THAT THE DEVICE'S 510 K NUMBER IS K093905. SECTION G5 HAS BEEN AMENDED TO REFLECT THE CORRECT 510K NUMBER OF K093416.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "VENTILATOR INOPERATIVE" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD AND POWER MANAGEMENT BOARD NEED REPLACED TO ADDRESS THE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893460 | TRILOGY 200 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC | 1032800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |