FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 3910630
·
Received July 2, 2014
Report
- Report Number
- 2031642-2014-00601
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Report Date
- June 9, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CHECK VALVE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR FAILED PRE-USE TESTING DUE TO A LEAK AT THE INSPIRATORY NON-REBREATHING CHECK VALVE. THE VENTILATOR WAS NOT IN USE ON A PATIENT. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE ENGINEER REPORTED THE CHECK VALVE BODY WAS SEPARATED FROM THE OUTER RING, WHICH MAY RESULT IN BLOCKED AIRFLOW THROUGH THE GAS PATH OF THE ASSEMBLY. THE SERVICE ENGINEER REPLACED THE CHECK VALVE TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388183 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |