FDA Adverse Event
Malfunction
Summary report: N
CXDI-70C
MDR report key: 3491886
·
Received October 18, 2013
Report
- Report Number
- 1000181430-2013-00138
- Event Type
- Malfunction
- Date Received
- October 18, 2013
- Date of Event
- September 16, 2013
- Report Date
- September 19, 2013
- Manufacturer
- CANON, INC.
- Product Code
- MQB
- PMA / PMN Number
- K102012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE BATTERY COMPARTMENT WAS REPLACED BY SERVICE ENGINEER OF CANON U.S.A., INC. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER STATED PATIENT WAS EXPOSED BUT NO IMAGES SHOWN UP ON THE SCREEN. PATIENT WAS TAKEN TO ANOTHER ROOM TO FINISH THE EXAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536321 | CXDI-70C | MQB | CANON, INC. | CXDI-70C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |