FDA Adverse Event
Malfunction
Summary report: N
TRILOGY EVO
MDR report key: 16194059
·
Received January 18, 2023
Report
- Report Number
- 2518422-2023-01875
- Event Type
- Malfunction
- Date Received
- January 18, 2023
- Date of Event
- December 22, 2022
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959051942
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ON THE PREVIOUSLY SUBMITTED REPORT SECTION E WAS WRONG. IN THIS REPORT SECTION E HAS BEEN UPDATED/CORRECTED.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM 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 MACHINE FLOW SENSOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE. THERE WAS EVIDENCE OF CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1068534 | TRILOGY EVO | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | DS2110X11B | 00606959051942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |