FDA Adverse Event
Malfunction
Summary report: N
TRILOGY EV300
MDR report key: 18094993
·
Received November 8, 2023
Report
- Report Number
- 2518422-2023-29494
- Event Type
- Malfunction
- Date Received
- November 8, 2023
- Date of Event
- October 24, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- UDI-DI
- 00606959052017
- PMA / PMN Number
- K181166
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR IS FAILING THE ACTIVE EXHALATION PERFORMANCE VERIFICATION TESTING. THERE WAS NO ALLEGATION OF HARM OR SERIOUS INJURY REPORTED. NO MEDICAL INTERVENTION WAS SPECIFIED. THE CUSTOMER (BIOMED) HAS TAKEN RESPONSIBILITY FOR REPAIRING THE DEVICE. DURING THE EVALUATION OF THE DEVICE AT THE CUSTOMER SITE THE BIOMED REPLACED THE AECM PROPORTIONAL VALVE RETURNING THE DEVICE TO FULL FUNCTIONALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813276 | TRILOGY EV300 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | DS2200X11B | 00606959052017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |