FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 2852110
·
Received November 14, 2012
Report
- Report Number
- 2518422-2012-02254
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MFR FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |