FDA Adverse Event
Malfunction
Summary report: N
TRILOGY EVO
MDR report key: 18160857
·
Received November 17, 2023
Report
- Report Number
- 2518422-2023-30925
- Event Type
- Malfunction
- Date Received
- November 17, 2023
- Date of Event
- November 13, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959055483
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IN THE PREVIOUSLY SUBMITTED REPORT, THE MANUFACTURER INITIALLY LEFT THE REPORTER COUNTRY BLANK. IN THIS REPORT, THE MANUFACTURER HAS UPDATED THE REPORTER COUNTRY TO KOREA DEMOCRATIC PEOPLES REPUBLIC. SECTION E HAS BEEN UPDATED IN THIS REPORT.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 986497 | TRILOGY EVO | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | KR2110X15B | 00606959055483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |