FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3813584
·
Received March 26, 2014
Report
- Report Number
- 2518422-2014-00513
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Date of Event
- February 27, 2014
- Report Date
- February 27, 2014
- Manufacturer
- RESEPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LCD DISPLAY SCREEN WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S DISPLAY SCREEN WAS DAMAGED. THE DEVICE WAS NOT IN PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176645 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESEPIRONICS, INC. | 1054096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |