FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RADIOGRAPHY CXDI-70C WIRELESS
MDR report key: 2897183
·
Received December 31, 2012
Report
- Report Number
- 1000181430-2012-00217
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Manufacturer
- CANON, INC.
- Product Code
- MQB
- PMA / PMN Number
- K102012
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY (B)(4). THE CUSTOMER WAS ADVISED TO UPDATE THE SOFTWARE TO VERSION 1.4. THE UPGRADE WAS PERFORMED. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TWO ERROR CODES DISPLAYED ON THE SYSTEM. THE ERROR CODES WERE SUCH THAT THERE WAS A POSSIBLE MISSING IMAGE. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL RADIOGRAPHY CXDI-70C WIRELESS | MQB | CANON, INC. | CXDI-70 WIRELESS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |