MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-09 for KODAK EKTASCAN LASER PRINTER 2180 1259965 manufactured by Eastman Kodak Co. Health Imaging Division.
[20136797]
The latching mechanism of the film supply magazine has a mechanism that guards against the lid of the film magazine falling down unexpectedly on someone's hand during the loading of film. A cap screw in this mechanism was loose and mechanism failed. The result was the lid fell on the technician's hand while she was loading the film. This resulted in a fracture to her hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-1999-00001 |
| MDR Report Key | 249561 |
| Report Source | 05,06 |
| Date Received | 1999-11-09 |
| Date of Report | 1999-11-08 |
| Date of Event | 1999-10-08 |
| Date Mfgr Received | 1999-10-08 |
| Date Added to Maude | 1999-11-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JUDITH WALLACE |
| Manufacturer Street | 91 ELMGROVE RD |
| Manufacturer City | ROCHESTER NY 14653 |
| Manufacturer Country | US |
| Manufacturer Postal | 14653 |
| Manufacturer Phone | 7167246111 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK EKTASCAN LASER PRINTER 2180 |
| Generic Name | X-RAY MEDICAL IMAGER- |
| Product Code | LMC |
| Date Received | 1999-11-09 |
| Model Number | 2180 |
| Catalog Number | 1259965 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 241780 |
| Manufacturer | EASTMAN KODAK CO. HEALTH IMAGING DIVISION |
| Manufacturer Address | 343 STATE ST. ROCHESTER NY 14650 US |
| Baseline Brand Name | KODAK EKTASCAN LASER PRINTER 2180 |
| Baseline Generic Name | X-RAY MEDICA IMAGER |
| Baseline Model No | 2180 |
| Baseline Catalog No | 1259965 |
| Baseline ID | * |
| Baseline Device Family | EKTASCAN LASER PRINTER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921743 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-09 |