FDA Adverse Event
Malfunction
Summary report: N
FCR GO2 PORTABLE DIGITAL X-RAY
MDR report key: 2750140
·
Received September 14, 2012
Report
- Report Number
- 2443168-2012-00001
- Event Type
- Malfunction
- Date Received
- September 14, 2012
- Date of Event
- July 21, 2012
- Report Date
- September 5, 2012
- Manufacturer
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- Product Code
- IZL
- PMA / PMN Number
- K080945
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A USER REPORTED THE FOLLOWING: PRIOR TO TRANSPORTING FUJIFILM'S FCR GO2 PORTABLE DIGITAL X-RAY DEVICE TO THE PT'S BEDSIDE, TECHNICIANS SET THE IMAGING PARAMETERS ON THE DEVICE'S PANEL. THE DEVICE WAS MOVED TO THE PT'S BEDSIDE, THE PT POSITIONED AND AN IMAGE WAS TAKEN. THE USER REPORTS THAT ON ACTIVATING THE LIGHT FIELD ILLUMINATOR SWITCH THE MENU PARAMETERS REVERTED TO "THE PROGRAMMED SETTING." THE USER REPORTED THAT THE PT CONSEQUENTLY RECEIVED A HIGHER DOSE OF RADIATION THAN INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FCR GO2 PORTABLE DIGITAL X-RAY | PORTABLE DIGITAL X-RAY | IZL | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FCR GO2 MB 201 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |