FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3941642
·
Received March 5, 2014
Report
- Report Number
- 2518422-2014-00326
- Event Type
- Malfunction
- Date Received
- March 5, 2014
- Date of Event
- February 11, 2014
- Report Date
- February 11, 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, "SERVICE REQUIRED" CODES WERE FOUND IN VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132376 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |