FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 4882357
·
Received July 1, 2015
Report
- Report Number
- 2518422-2015-01857
- Event Type
- Malfunction
- Date Received
- July 1, 2015
- Date of Event
- June 5, 2015
- Report Date
- June 5, 2015
- Manufacturer
- RESPIRONICS, INC
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. 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 INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE ACTIVE EXHALATION CONTROL MODULE WAS FOUND TO BE DAMAGED. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428088 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |