FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1162219
·
Received September 16, 2008
Report
- Report Number
- 2031642-2008-00199
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 19, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR RESTARTED AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. HOWEVER, THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY THAT INDICATED A VENTILATOR RESTART. THE SERVICE TECHNICIAN REPLACED THE POWER SWITCH AS A PRECAUTION. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL 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 | UNK |