FDA Adverse Event
Malfunction
Summary report: N
CXDI CONTROL SOFTWARE NE VER. 1.40.3.0
MDR report key: 2911141
·
Received December 6, 2012
Report
- Report Number
- 1000181430-2012-00068
- Event Type
- Malfunction
- Date Received
- December 6, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- CANON, INC.-MEDICAL EQUIPMENT GROUP
- Product Code
- MQB
- PMA / PMN Number
- K062221
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION IS STILL IN-PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED PER 21 CFR 803.56. (B)(4).
Description of Event or Problem · 1
DURING A STITCHING EXAM, THE TECHNOLOGIST TOOK THE FIRST EXPOSURE, THEN THE NE COMPUTER HAD AN ERROR AND SHUT DOWN. WHEN THE COMPUTER WAS RESTARTED, THE EXAM WAS STILL THERE BUT THE IMAGE WAS MISSING. THEY RE-EXPOSED THE PATIENT AND THE NEXT THREE IMAGES IN THE EXAM WERE CAPTURED WITHOUT PROBLEMS. THE STITCHING EXAM WAS COMPLETED. THE FIRST TWO IMAGES ARE EMPTY, BUT THE LAST THREE IMAGES WERE CAPTURED CORRECTLY. ONE PATIENT HAD TO HAVE ONE EXTRA X-RAY EXPOSURE, RESULTING IN UNINTENDED RADIATION EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CXDI CONTROL SOFTWARE NE VER. 1.40.3.0 | MQB | CANON, INC.-MEDICAL EQUIPMENT GROUP | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |