FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 3972885
·
Received July 8, 2014
Report
- Report Number
- 2031642-2014-00633
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Report Date
- June 11, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE BATTERY WAS RECHARGED AND PASSED ALL TESTING.
Description of Event or Problem · 1
DURING SERVICE FOR AN UNRELATED ISSUE THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) REVIEWED THE DEVICE DIAGNOSTIC LOG AND NOTED A 24/+-12V/POWER FAIL OCCURRENCE, AND VERIFIED THE DEVICE WAS OPERATING ON BACKUP BATTERY POWER AND THE BACKUP BATTERY FUNCTIONED UNTIL IT DEPLETED AS A RESULT OF USE, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. THE DEVICE POWERED UP ON BATTERY INDICATING THE BATTERY HAD RECHARGED. THE FSE PERFORMED BATTERY TESTING UNIT, ALL BATTERY TESTING PASSED. THERE WERE NO PARTS REPLACED. THE CUSTOMER REPORTED NO PT INVOLVEMENT THEREFORE NO PT HARM. THE DEVICE PASSED ALL MANUFACTURER'S REQUIRED TESTING TO SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397841 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS, PRODUCT CODE: CBK | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |