MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-13 for ZEISS CIRRUS 4000 SD-OCT manufactured by Zeiss.
[18569503]
The cirrus model 4000 spectral domain optical coherence tomography (oct) unit that we use for screening tests for glaucoma does a "guided progression analysis" whereby the pt's prior tests are compared to the current day's testing in order to detect changes. On this day, one pt's gpa analysis for one eye imported 2 previous exams from the wrong eye of the wrong pt. This wrong pt had testing on the same 2 days in the past as pt kp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031841 |
| MDR Report Key | 3354824 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-09-12 |
| Date of Event | 2013-08-07 |
| Date Added to Maude | 2013-09-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEISS CIRRUS |
| Generic Name | CIRRUS |
| Product Code | OBO |
| Date Received | 2013-09-13 |
| Model Number | 4000 SD-OCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZEISS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-13 |