FDA Adverse Event
Injury
Summary report: N
SHIMADZU MOBILEDART EVOLUTION
MDR report key: 5419391
·
Received January 15, 2016
Report
- Report Number
- 1000125362-2016-00001
- Event Type
- Injury
- Date Received
- January 15, 2016
- Date of Event
- November 25, 2015
- Report Date
- January 5, 2016
- Manufacturer
- SHIMADZU MEDICAL SYSTEMS
- Product Code
- IZL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER/DEALER REPORTED THAT THE CABLE OF THE POWER CODE WAS BURNT BY SHORT-CIRCUITING WHEN PLUGGING THE POWER CORD. THE DETAIL CAUSE IS UNDER INVESTIGATION. MFR # 8030233-2016-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30680 | SHIMADZU MOBILEDART EVOLUTION | MOBILE X-RAY SYSTEM | IZL | SHIMADZU MEDICAL SYSTEMS | MOBILEDART EVOLUTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |