MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-04 for FUJI FCR XG5000 CR IR 362 manufactured by Fujifilm Medical System, Usa, Inc..
[1061586]
While tech was developing an x-ray image in the fuji cr reader, he noticed prior to sending to pacs, that images were incorrect. They "jumped into another patient's jacket". A service call was placed and fuji service engineer came in. Logs were sent to japan for review. A similar event occurred approximately a year ago. The hospital believes that this problem may be triggered when a jam of a cr cassette occurs, and the cr reader is re-booted to clear the jam. Under these circumstances it appears that the cr image may be stored in the proper (new) patient's folder, as well as in the previous patient's folder (bearing the accession number of the new patient). Fuji identified the cause of the issue and has installed a software upgrade version 2. 5 in the cr reader, which they have stated will prevent a repeat occurrence of this problem. The hospital has 13 of these cr readers and is in the process of having the upgrade installed in the other readers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1341457 |
| MDR Report Key | 1341457 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-03-04 |
| Date of Event | 2009-02-02 |
| Report Date | 2009-03-04 |
| Date Reported to FDA | 2009-03-04 |
| Date Added to Maude | 2009-03-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | FUJI FCR XG5000 |
| Generic Name | COMPUTED RADIOGRAPHY PLATE READER |
| Product Code | IXW |
| Date Received | 2009-03-04 |
| Model Number | FCR XG5000 |
| Catalog Number | CR IR 362 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM MEDICAL SYSTEM, USA, INC. |
| Manufacturer Address | 419 WEST AVENUE STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-04 |