MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-24 for MAMMOGRAPHY FILM PROCESSOR M35A-M manufactured by Eastman Kodak Co..
[26880]
Unable to process mammography x-ray films due to poor design. The processor in question was installed in 6/94, since then numerous problems have occurred. A distinct flame pattern on film was from a poor design in the developer recirculation system. Roller marks were being left on films from poorly designed developer rolers and crossover racks which made radiographs unacceptable by acr. Defective temp control microprocessor board rendered the processor unable to process mammography films. The last problem that was encountered was an icicle pattern on the film that could not correct, and was caused by the faulty rack system. Since this unit was installed in 6/94 this unit has yet to process an acceptable x-ray film. Co svc and repair personnel have made numerous attempts to repair this unit without success.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001374 |
| MDR Report Key | 33819 |
| Date Received | 1996-05-24 |
| Date of Report | 1994-12-12 |
| Date Added to Maude | 1996-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMMOGRAPHY FILM PROCESSOR |
| Generic Name | MAMMOGRAPHY FILM PROCESSOR |
| Product Code | IXW |
| Date Received | 1996-05-24 |
| Model Number | M35A-M |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35169 |
| Manufacturer | EASTMAN KODAK CO. |
| Manufacturer Address | BLDG 69 7TH FLOOR KODAK PARK ROCHESTER NY 14650 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-24 |