FDA Adverse Event
Malfunction
Summary report: N
V200 VENTILATOR
MDR report key: 9555767
·
Received January 6, 2020
Report
- Report Number
- 2031642-2020-00078
- Event Type
- Malfunction
- Date Received
- January 6, 2020
- Report Date
- October 11, 2019
- 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
Additional Manufacturer Narrative · 1
DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 01/06/2020.
Description of Event or Problem · 1
THE CUSTOMER REPORTED NO FLOW DETECTED. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. THE CUSTOMER WAS ADVISED TO PURCHASE THE FLOW SENSOR. THE REPAIR WAS COMPLETED BY A THIRD PARTY MAINTENANCE COMPANY AND NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19072 | V200 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS CALIFORNIA, INC | V200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |