FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 18657864
·
Received February 7, 2024
Report
- Report Number
- 2518422-2024-06046
- Event Type
- Malfunction
- Date Received
- February 7, 2024
- Date of Event
- January 31, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959026353
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION STATING THE TRILOGY 100 VENTILATOR DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS FOR THE FOLLOWING CONDITIONS: CRITICAL ERROR 177, 193, 290 AND 291, (COSMETIC) MISSING FEET. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE POWERED ON AND OPERATED AS IT SHOULD. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE INLET AIR PATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WERE REPLACED PER REMEDIATION. THE CUSTOMER DOES NOT WANT THE DEVICE REPAIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1366578 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054260B | 00606959026353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |