FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RADIOGRAPHY CXDI-55G
MDR report key: 2897196
·
Received December 31, 2012
Report
- Report Number
- 1000181430-2012-00224
- Event Type
- Malfunction
- Date Received
- December 31, 2012
- Report Date
- May 9, 2012
- Manufacturer
- CANON, INC.
- Product Code
- MQB
- PMA / PMN Number
- K091435
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 CANNON HEALTHCARE SOLUTIONS USA. (B)(4). THE SERVICE ENGINEER WAS NOT ABLE TO DUPLICATE THE REPORTED PROBLEM. HE RE-WROTE THE FIRMWARE AND PLD CODE. HE PERFORMED THE CALIBRATION AND SELF TESTS, AND ALL FUNCTIONS MET SPECS. MANUFACTURER CROSS-REFERENCE #: (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN ERROR CODE DISPLAYED ON THE SYSTEM. THE ERROR CODE WAS SUCH THAT THE IMAGE WOULD HAVE BEEN RETAKEN. THE RETAKE OF THE IMAGE WOULD HAVE RESULTED IN UNINTENDED RADIATION EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL RADIOGRAPHY CXDI-55G | MQB | CANON, INC. | CXDI-55G | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |