MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-25 for FUJI COMPUTED RADIOGRAPHY FCR 9000 SYSTEM CRIR317 XIR9000I manufactured by Fuji Photo Film Co., Ltd..
[97173]
The customer reported that an image for one pt was associated with the identification info of another pt.
Patient Sequence No: 1, Text Type: D, B5
[7780821]
Representatives from service and technical support depts evaluated the device in question and found no defects or discrepancies. The service and technical support depts could not find the exact cause of this condition. However, the reported condition can be duplicated if: 1) the operator does not clear the previous pt identification info after rebooting the device. Or 2) the clocks in the id terminals disagree. Or 3) the id for a newly composed imaging plate remains unprocessed for some reason when it is read without deliberately accomplishing id registration, the system will process the imaging plate on the basis of the id info, judging that id registration has been completed. Co reviewed the records and found this to be an isolated incident. Although co has no other reports of this nature, to reduce the potential for this type of event, co created and has implemented software upgrade version idt718/719 version 10. Based on the above info co's investigation has been concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2443168-1998-00001 |
| MDR Report Key | 159942 |
| Report Source | 05,06 |
| Date Received | 1998-03-25 |
| Date of Report | 1998-03-25 |
| Date of Event | 1998-02-25 |
| Date Mfgr Received | 1998-02-25 |
| Date Added to Maude | 1998-04-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJI COMPUTED RADIOGRAPHY FCR 9000 SYSTEM |
| Generic Name | COMPUTED RADIOGRAPHY SYSTEM |
| Product Code | IXK |
| Date Received | 1998-03-25 |
| Model Number | CRIR317 |
| Catalog Number | XIR9000I |
| 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 | 155768 |
| Manufacturer | FUJI PHOTO FILM CO., LTD. |
| Manufacturer Address | 26-30 NISHIAZABU 2-CHOME MINATO-KU TOKYO JA 106-8620 |
| Baseline Brand Name | FUJI COMPUTED RADIOGRAPHY FCR 9000 SYSTEM |
| Baseline Generic Name | COMPUTED RADIOGRAPHY SYSTEM |
| Baseline Model No | CRIR317 |
| Baseline Catalog No | XIR90000I |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-25 |