FDA Adverse Event
Malfunction
Summary report: N
TRILOGY
MDR report key: 21368808
·
Received February 12, 2025
Report
- Report Number
- 2518422-2025-101981
- Event Type
- Malfunction
- Date Received
- February 12, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PREVIOUSLY THE MANUFACTURER SENT A CORRECTION INCORRECTLY RESULTING IN A RECORD BEING CREATED FOR MDR 2518422-2025-101981. THIS IS A DUPLICATE OF MDR 2518422-2025-101807. A CORRECTED REPORT WILL BE FILED UNDER MDR 2518422-2025-101807. ALL REPORTING WILL BE ADDRESSED UNDER MDR 2518422-2025-101807.
Additional Manufacturer Narrative · 0
THE MANUFACTURER PREVIOUSLY REPORTED THE BECOME AWARE DATE OF 01/13/2025. THIS REPORT IS BEING SENT TO CORRECT THE BECOME AWARE DATE TO 01/20/2025. THE DUE DATE AND THE DATE RECEIVED BY THE MANUFACTURER HAVE BEEN UPDATED TO REFLECT THE CHANGE.
Description of Event or Problem · 0
SERMAX CASE 0124832503/TRILOGY DEVICE/GB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 966636 | TRILOGY | CBK | RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |