FDA Adverse Event
Malfunction
Summary report: N
V200 VENTILATOR
MDR report key: 3951103
·
Received July 22, 2014
Report
- Report Number
- 2031642-2014-00711
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Report Date
- June 29, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K102054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR ALARMED VENT INOP AND WOULD NOT BOOT UP DUE TO AN AIR VALVE LIFTOFF FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE ENGINEER REPLACED THE BLOWER MOTOR CONTROLLER PCB BOARD TO ADDRESS THE REPORTED PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427670 | V200 VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |