FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3012849
·
Received February 5, 2013
Report
- Report Number
- 2518422-2013-00149
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- 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, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MFR FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49941 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |