FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 4110233
·
Received September 10, 2014
Report
- Report Number
- 2518422-2014-01539
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Date of Event
- August 14, 2014
- Report Date
- August 14, 2014
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFO ALLEGING A VENTILATOR'S INTERNAL BATTERY WOULD NOT FUNCTION. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559501 | TRILOGY 100 | CBK | RESPIRONICS INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |