FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 23377460
·
Received October 24, 2025
Report
- Report Number
- 2518422-2025-049970
- Event Type
- Malfunction
- Date Received
- October 24, 2025
- Date of Event
- August 21, 2025
- Report Date
- October 24, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959015364
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231820 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054260 | 00606959015364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |