MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,company representative, report with the FDA on 2014-12-30 for FORUM VIEWER 000000-2058-601 manufactured by Carl Zeiss Meditec Ag.
[16448681]
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 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
[28569153]
Change "initial", "30-day" to "follow-up # 1";. The manufacturer has initiated an action that was reported to the fda under 21 usc 360i(f). The software was corrected at the foreign site where the malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[28569154]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2014-00004 |
| MDR Report Key | 4384252 |
| Report Source | 01,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-30 |
| Date of Report | 2015-09-16 |
| Date of Event | 2014-11-24 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2015-01-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA SITE) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1049-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORUM VIEWER |
| Generic Name | PICTURE ARCHIVE AND COMMUNICATIONS S |
| Product Code | NFJ |
| Date Received | 2014-12-30 |
| Model Number | NA |
| Catalog Number | 000000-2058-601 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NUCLEAR MEDICINE TECHNOLOGIST |
| 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 | 2014-12-30 |