MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-01-16 for FORUM VIEWER 000000-2058-601 manufactured by Carl Zeiss Meditec Ag.
[19767470]
The healthcare provider reported that although the highlighted b-scan in the optical coherence tomography 5-hd raster scan overlay on the reference fundus image matched the intended selection, the retinal b-scan tomogram displayed by forum viewer software v. 3. 2. 1 for the patient was not the b-scan tomogram selected. For the patient was not the b-scan tomogram selected. For example, b-scan number 3 of 5 was highlighted in the fundus image but b-scan number 1 of 5 was displayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2015-00001 |
| MDR Report Key | 4436982 |
| Report Source | 01,07 |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-12-10 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-02-04 |
| 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 | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA 07746 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07746 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORUM VIEWER |
| Generic Name | PICTURE ARCHIVE AND COMMUNICATIONS |
| Product Code | NFJ |
| Date Received | 2015-01-16 |
| Model Number | NA |
| Catalog Number | 000000-2058-601 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | JENA GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-16 |