FDA Adverse Event
Malfunction
Summary report: N
ESPIRIT VENTILATOR
MDR report key: 1060142
·
Received June 11, 2008
Report
- Report Number
- 2031642-2008-00144
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- May 22, 2008
- Report Date
- May 22, 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
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OXYGEN VALVE ASSEMBLY
Description of Event or Problem · 1
WHILE THE SERVICING THE VENTILATOR, THE MFR'S SVC TECH NOTED A DIAGNOSTIC CODE IN THE VENTILATOR'S CODE LOG HISTORY INDICATING A VENT INOP OCCURRENCE DUE TO AN OXYGEN MOTOR ERROR. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE. WHEN QUESTIONED ABOUT THE VENT INOP OCCURRENCE, THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PT AND DID ALARM. THE CUSTOMER REPORTED THERE WAS NO PT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PT. THE SVC TECH REPLACED THE OXYGEN VALVE ASSEMBLY TO CORRECT THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECS.
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 | UNK |