FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3030813
·
Received March 27, 2013
Report
- Report Number
- 2518422-2013-00452
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- 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, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126127 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |