FDA Adverse Event
Malfunction
Summary report: N
FLOWMETER, BLOOD, CARDIOVASCULAR
MDR report key: 6916092
·
Received October 5, 2017
Report
- Report Number
- 6916092
- Event Type
- Malfunction
- Date Received
- October 5, 2017
- Date of Event
- September 27, 2017
- Report Date
- September 28, 2017
- Manufacturer
- PARKS MEDICAL ELECTRONICS, INC.
- Product Code
- DPW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE DEVICE WOULD NOT TURN ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697605 | FLOWMETER, BLOOD, CARDIOVASCULAR | DPW | PARKS MEDICAL ELECTRONICS, INC. | 811-BTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |