FDA Adverse Event
Malfunction
Summary report: N
TRILOGY EVO
MDR report key: 18239737
·
Received November 30, 2023
Report
- Report Number
- 2518422-2023-32741
- Event Type
- Malfunction
- Date Received
- November 30, 2023
- Date of Event
- November 16, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959051942
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING FILED AS A CORRECTION TO A DUPLICATE. PLEASE REFER TO PR 4133916 MDR 2518422-2023-32968 FOR ALL REPORTING.
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 MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1845443 | TRILOGY EVO | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | DS2110X11B | 00606959051942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |