FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 4102624
·
Received August 28, 2014
Report
- Report Number
- 2518422-2014-01509
- Event Type
- Malfunction
- Date Received
- August 28, 2014
- Date of Event
- August 5, 2014
- Report Date
- August 5, 2014
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS EVALUATED AT THE THIRD PARTY SERVICE CENTER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LOW FLOW OXYGEN TUBING WAS RECONNECTED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER WITH AN ALLEGATION THE DEVICE'S OXYGEN PORT WAS LEAKING. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523976 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |