FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1811538
·
Received August 23, 2010
Report
- Report Number
- 2031642-2010-00233
- Event Type
- Malfunction
- Date Received
- August 23, 2010
- Date of Event
- July 23, 2010
- Report Date
- July 26, 2010
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
POWER SUPPLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND RESTARTED AND WENT VENT INOP UPON RESTART. THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURER'S FIELD SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT, HOWEVER CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A +24/+-12 VOLT FAILURE AND RESTART OF THE VENTILATOR. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND 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 |