MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2013-01-28 for DIGITAL RETINAL CAMERA CX-1 3940B008AA manufactured by Canon Inc..
[3173238]
The customer reported that they were getting a shadow of the split bar assembly (in the image), as a result of a split drive unit failure. 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.
Patient Sequence No: 1, Text Type: D, B5
[10507864]
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 adjusted the optical sensor in the split line assembly. This resolved the issue and there have been no more problems. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000181430-2013-00029 |
| MDR Report Key | 2980345 |
| Report Source | 00,01 |
| Date Received | 2013-01-28 |
| Date of Report | 2012-08-15 |
| Date Mfgr Received | 2012-08-15 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2013-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NAOYASU ASAKA |
| Manufacturer Street | 30-2 SHIMOMARUKO, 3-CHOME |
| Manufacturer City | OHTA, KU, TOKYO 146-8501 |
| Manufacturer Country | JA |
| Manufacturer Postal | 146-8501 |
| Manufacturer Phone | 37582111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGITAL RETINAL CAMERA CX-1 |
| Product Code | NFJ |
| Date Received | 2013-01-28 |
| Model Number | CX-1 |
| Catalog Number | 3940B008AA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON INC. |
| Manufacturer Address | TOKYO 146-8501 146-8501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-28 |