MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-01 for CASSINI manufactured by I-optics Bv.
[5132842]
After upgrading the cassini software at a customer by an i-optics' representative, a new patient was scanned. The i-optics employee discovered that this patient examination data was linked to another (previously) scanned patient. All other patient records were checked by the customer and i-optics employee to confirm no charts would be affected. No pt data was used for diagnosis or therapeutic treatment between the update and record integrity check. No pts were affected. The issue was immediately reported to i-optics bv.
Patient Sequence No: 1, Text Type: D, B5
[12767309]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008251789-2014-00001 |
| MDR Report Key | 4322193 |
| Report Source | 07 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2014-11-17 |
| Date Added to Maude | 2014-12-17 |
| 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 L HELLER, MANAGER |
| Manufacturer Street | MAURITSKADE 35 |
| Manufacturer City | THE HAQUE 00002514 |
| Manufacturer Country | NL |
| Manufacturer Postal | 00002514 |
| Manufacturer Phone | 03993112 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASSINI |
| Generic Name | CORNEAL TOPOGRAPHER SYSTEM |
| Product Code | MMQ |
| Date Received | 2014-12-01 |
| Lot Number | SOFTWARE V2.0.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | I-OPTICS BV |
| Manufacturer Address | MAURITSKADE 35 THE HAQUE 352514 H NL 352514 HD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-01 |