FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 202
MDR report key: 2820285
·
Received October 31, 2012
Report
- Report Number
- 2518422-2012-02172
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 2, 2012
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K093905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S AC POWER CORD WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MFR RECEIVED INFO ALLEGING A VENTILATOR WOULD NOT POWER ON. THE DEVICE WAS NOT IN PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY 202 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1040007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |