FDA Adverse Event
Malfunction
Summary report: N
FDR GO
MDR report key: 6082330
·
Received November 7, 2016
Report
- Report Number
- 8030233-2016-00004
- Event Type
- Malfunction
- Date Received
- November 7, 2016
- Date of Event
- September 7, 2016
- Report Date
- March 29, 2017
- Manufacturer
- SHIMADZU COPORATION
- Product Code
- IZL
- PMA / PMN Number
- K080701
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A RESULT OF CONTACT WITH IMPORTER, WE HAVE CONFIRMED THAT THE PLUG WAS NOT SEPARATE FROM POWER CORD.
Description of Event or Problem · 1
USER REPORTED THAT WHEN THEY PLUGGED THE FDR GO MOBILE X-RAY SYSTEM IN THERE WAS A LARGE SPARK AND THE PLUG SEPARATED FROM THE POWER CORD. NO ONE WAS HURT BY THE PLUG SPARKING. THE USER ALSO REPORTED THAT THE PLUG WAS HOT WHEN UNPLUGGED AT THE START OF THE DAY (UNITS ARE TYPICALLY PLUGGED IN TO CHANGE OVERNIGHT. THE SYSTEM WAS ON WHEN HE PLUGGED IN THE SYSTEM. WE HAVE RECEIVED FROM IMPORTER/DISTRIBUTOR THE ABOVE REPORT AT 10/07/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735951 | FDR GO | MOBILE X-RAY SYSTEM | IZL | SHIMADZU COPORATION | 503-79200-11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |