FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 3111604
·
Received May 6, 2013
Report
- Report Number
- 2518422-2013-00767
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE LCD DISPLAY SCREEN WAS OBSERVED TO HAVE PHYSICAL DAMAGE (CRACKED). 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 LCD DISPLAY SCREEN WAS DISTORTED. THE DEVICE WAS NOT IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197500 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |