FDA Adverse Event
Malfunction
Summary report: N
PACSCUBE
MDR report key: 6055753
·
Received October 25, 2016
Report
- Report Number
- 3003341080-2016-00003
- Event Type
- Malfunction
- Date Received
- October 25, 2016
- Date of Event
- October 5, 2016
- Report Date
- October 25, 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
TRANSFER RIBBON STARTED SMOKING IN THE ROBOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706709 | PACSCUBE | DIGITAL IMAGE COMMUNICATIONS DEVICE | LMD | DATCARD SYSTEMS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |