FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100 VENTILATOR
MDR report key: 23319389
·
Received October 16, 2025
Report
- Report Number
- 2518422-2025-049790
- Event Type
- Malfunction
- Date Received
- October 16, 2025
- Date of Event
- September 24, 2025
- Report Date
- October 17, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959015364
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. THE DEVICE PASSED ALL TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2098216 | TRILOGY 100 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054260 | 00606959015364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |