FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 4180771
·
Received October 15, 2014
Report
- Report Number
- 2518422-2014-01788
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 29, 2014
- Report Date
- September 29, 2014
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, DAMAGE TO THE REMOTE ALARM CONNECTOR WAS OBSERVED. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MANUFACTURER 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 |
|---|---|---|---|---|---|---|---|
| 653025 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |