FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 4102459
·
Received August 27, 2014
Report
- Report Number
- 2518422-2014-01469
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- July 31, 2014
- Report Date
- July 31, 2014
- 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 EVALUATION 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
THE MFR RECEIVED INFO ALLEGING A VENTILATOR WAS ALARMING. THE DEVICE WAS NOT IN PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518968 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC., | 1054655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |