FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1952894
·
Received January 7, 2011
Report
- Report Number
- 2031642-2011-00010
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- December 12, 2010
- Report Date
- December 14, 2010
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRINTED CIRCUIT BOARD (PCB).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR SCREEN WENT BLANK, THEN SHUT DOWN AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECH CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A VENTILATOR RESTART HAD OCCURRED. THE SERVICE TECHNICIAN REPLACED THE VGA PCB BOARD TO ADDRESS THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO 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 |