FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 202
MDR report key: 2854277
·
Received November 28, 2012
Report
- Report Number
- 2518422-2012-02351
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K093905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE OXYGEN BLENDING MODULE PCA AND SYSTEM PCA WERE REPLACED TO ADDRESS THE ISSUES.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY 202 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1040007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |