FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3880784
·
Received April 9, 2014
Report
- Report Number
- 2518422-2014-00575
- Event Type
- Malfunction
- Date Received
- April 9, 2014
- Date of Event
- March 17, 2014
- Report Date
- March 17, 2014
- 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 "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICES" SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THESE ISSUES.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFO ALLEGING A VENTILATOR WAS CONTINUOUSLY ALARMING. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214294 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |