FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 2575682
·
Received May 2, 2012
Report
- Report Number
- 2518422-2012-00562
- Event Type
- Malfunction
- Date Received
- May 2, 2012
- Date of Event
- April 9, 2012
- Report Date
- April 9, 2012
- Manufacturer
- RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVAL OF THE DEVICE AT THE MFR¿S SERVICE CENTER, A ¿SERVICE REQUIRED¿ CODE WAS FOUND AND A FAILURE OF THE ACTIVE EXHALATION CONTROL MODULE WERE OBSERVED. THE DEVICE¿S ACTIVE EXHALATION CONTROL MODULE AND SENSOR PCA WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MFR RECEIVED INFO ALLEGING A ¿SERVICE REQUIRED¿ ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | 1054655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |