FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 2131016
·
Received June 16, 2011
Report
- Report Number
- 2031642-2011-00206
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 19, 2011
- Report Date
- May 19, 2011
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN 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 CUSTOMER REPORTED EVENT. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG HISTORY OBSERVED NO VENT INOP OCCURRENCES. THE SERVICE TECHNICIAN REPLACED THE CPU PCB AS A PRECAUTION BASED ON THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTING 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 |