MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-17 for KODAK 2180 manufactured by Kodak.
[15615768]
New mri co laser printer installed 5/31/95. Different image size from new camera prevented verification of surgical coordinates on 6/9/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25764 |
| MDR Report Key | 25764 |
| Date Received | 1995-07-17 |
| Date of Report | 1995-06-29 |
| Date of Event | 1995-06-09 |
| Date Added to Maude | 1995-09-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK |
| Generic Name | EKTASCAN LASER CAMERA |
| Product Code | IXW |
| Date Received | 1995-07-17 |
| Model Number | 2180 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26365 |
| Manufacturer | KODAK |
| Manufacturer Address | 18325 WATERVIEW PKWY DALLAS TX 75252 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-17 |