FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 2173114
·
Received July 23, 2011
Report
- Report Number
- 2031642-2011-00226
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM, HOWEVER THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY INDICATING A VENT INOP OCCURRED DUE TO A PRESSURE SENSOR FAILURE. THE SERVICE TECHNICIAN PERFORMED EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |