FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 3933041
·
Received July 14, 2014
Report
- Report Number
- 2031642-2014-00672
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Report Date
- June 18, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR FAILED BACKUP BATTERY TESTING. THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. IF A LOSS OF POWER OCCURS DURING USE DUE TO THE BACKUP BATTERY NOT WORKING IT MAY RESULT IN THE UNIT SHUNTING DOWN. THE FSE REPLACED THE BACKUP BATTERY TO CORRECT THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410824 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |