FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 202
MDR report key: 3994286
·
Received July 23, 2014
Report
- Report Number
- 2518422-2014-01222
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 18, 2014
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K093905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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 DEVICE'S POWER MANAGEMENT WAS REPLACED TO ADDRESS THE ISSUES.
Description of Event or Problem · 1
THE MANUFACTURER REC'D INFO ALLEGING A VENTILATOR WAS ALARMING. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431093 | TRILOGY 202 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1040007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |