FDA Adverse Event
Malfunction
Summary report: N
ESPIRIT VENTILATOR
MDR report key: 1003323
·
Received February 27, 2008
Report
- Report Number
- 2031642-2008-00055
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 4, 2008
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED O2 VALVE STUCK CLOSED. THE VENTILATOR WAS NOT IN USE ON A PT ;THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. UPON DETECTION OF AN OXYGEN VALVE STUCK CLOSED, THE VENTILATOR WILL CONTINUE TO FUNCTION USING AN AIR GAS SOURCE. THE MFR'S SERVICE TECH WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECH CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY INDICATING DETECTION OF OXYGEN VALVE STUCK CLOSED. EXTENDED SELF TESTING (EST) AND APPLICABLE TESTING WAS COMPLETED AND THE UNIT PASSED ALL TESTS TO SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPIRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |