FDA Adverse Event
Malfunction
Summary report: N
PACSCUBE
MDR report key: 5605403
·
Received April 25, 2016
Report
- Report Number
- 3003341080-2016-00001
- Event Type
- Malfunction
- Date Received
- April 25, 2016
- Date of Event
- April 21, 2016
- Manufacturer
- DATCARD SYSTEMS, INC
- Product Code
- LMD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER PLUGGED MONITOR AND PC INTO THE POWER SUPPLY, THEN PLUGGED POWER SUPPLY INTO POWER OUTLET. WHEN HE PUSHED THE POWER BUTTON ON THE POWER SUPPLY, IT SPARKED AND BEGAN TO FLAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261632 | PACSCUBE | DIGITAL IMAGE COMMUNICATIONS DEVICE | LMD | DATCARD SYSTEMS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |