FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RETINAL CAMERA CF-1
MDR report key: 2980377
·
Received January 28, 2013
Report
- Report Number
- 1000181430-2013-00019
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- December 15, 2011
- Manufacturer
- CANON INC.
- Product Code
- HKI
- PMA / PMN Number
- K063717
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE DEALER SERVICE REPRESENTATIVE (OIS) SAID THAT HE WOULD TRY ANOTHER CAMERA BACK. NO SUBSEQUENT INFORMATION WAS PROVIDED. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE EOS (CAMERA BACK) WAS SHUTTING OFF BY ITSELF DURING USE. THE CUSTOMER DID NOT PROVIDE INFORMATION THAT THE PROBLEM AFFECTED IMAGES. THE CUSTOMER ALSO 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 |
|---|---|---|---|---|---|---|---|
| 38361 | DIGITAL RETINAL CAMERA CF-1 | HKI | CANON INC. | CF-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |