FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RETINAL CAMERA CX-1
MDR report key: 2980370
·
Received January 28, 2013
Report
- Report Number
- 1000181430-2013-00026
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- December 1, 2011
- Manufacturer
- CANON INC.
- Product Code
- NFJ
- PMA / PMN Number
- K092565
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE DEALER SERVICE REPRESENTATIVE REPLACED THE SPLIT DRIVE ASSEMBLY AND THE MAIN BOARD. THE SYSTEM IS WORKING FINE NOW. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A SHADOW ON THE LEFT SIDE OF THE IMAGE. NO INFORMATION WAS PROVIDED REGARDING WHAT IMAGE TYPES (COLOR, RED-FREE, FLUORESCEIN ANGIOGRAPHY) WERE AFFECTED. THE CUSTOMER DID NOT STATE THAT THE FLUORESCEIN IMAGING WAS REPEATED. HOWEVER, IF THE PROBLEM OCCURRED DURING THE FLUORESCEIN IMAGING PORTION OF THE EXAM, THE TECHNICIAN MAY HAVE RESCHEDULED THE EXAM. A RESCHEDULED EXAM WOULD HAVE INVOLVED A REPEAT INJECTION OF FLUORESCEIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37158 | DIGITAL RETINAL CAMERA CX-1 | NFJ | CANON INC. | CX-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |