FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 200
MDR report key: 2801082
·
Received October 17, 2012
Report
- Report Number
- 2518422-2012-02081
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 18, 2012
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K093416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INLET PORT TUBING WAS RECONNECTED TO ADDRESS THIS ISSUE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY 200 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1040005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |