TRILOGY 100
Report
- Report Number
- 2518422-2026-111619
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- April 5, 2024
- Report Date
- March 27, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959022744
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.
A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING FUNCTIONAL TESTING, THE DEVICE FAILED DUE TO A LOW FLOW CONDITION. REWORK WAS PERFORMED, INCLUDING ADDITION OF THE HLR STEP AND REPLACEMENT OF THE ACTIVE EXHALATION CONTROL MODULE AND 43-MICRON FILTER, FOLLOWED BY REPEAT RUN-IN AND FUNCTIONAL TESTING. AFTER REWORK, THE DEVICE SUCCESSFULLY PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS. VISUAL INSPECTION IDENTIFIED DUST CONTAMINATION WITHIN THE BLOWER BOX, WITH NO OTHER SIGNIFICANT ABNORMALITIES OBSERVED. DURING EVALUATION, ERROR CODES WERE OBSERVED. THE INTERNAL BATTERY WAS FOUND TO BE DEPLETED AND WAS RECHARGED. ADDITIONAL FINDINGS INCLUDED WORN O-RINGS REQUIRING REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780056 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054096 | 00606959022744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |