MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-13 for RESIUS 190 XPRES RESIUS 190 XPRESS * manufactured by Konica-minolta Medical Imaging Usa, Inc..
[21281596]
Of the 108 plates put into use, 60 plates have developed flaws or artifacts. These artifacts if not detected could result in additional diagnostic testing and potential harm. Beginning in sept 2007, this facility returned 28 of the 43 14" x 17" plates under warranty to konica and received replacement. Subsequently, an additional 41 plates were found to be flawed. Konica told this hospital that no other facilities have reported this type of issue. The artifact on the imaging plates appears as a small area(s) of higher attentuation that can be mistaken for calcification. We believe that the cause may be chips of glue which fall between the cover and the imaged storage plate. The glue is used to hold the metal frame surrounding the cassette.
Patient Sequence No: 1, Text Type: D, B5
[21424117]
Of the 108 plates put into use, 60 plates have developed flaws or artifacts. These artifacts if not detected could result in additional diagnostic testing and potential harm. Beginning in sept 2007, this facility returned 28 of the 43 14" x 17" plates under warranty to konica and received replacement. Subsequently, an additional 41 plates were found to be flawed. Konica told this hospital that no other facilities have reported this type of issue. The artifact on the imaging plates appears as a small area(s) of higher attentuation that can be mistaken for calcification. We believe that the cause may be chips of glue which fall between the cover and the imaged storage plate. The glue is used to hold the metal frame surrounding the cassette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1509706 |
| MDR Report Key | 1509706 |
| Date Received | 2009-10-13 |
| Date of Report | 2009-10-12 |
| Date of Event | 2009-10-12 |
| Report Date | 2009-10-12 |
| Date Reported to FDA | 2009-10-13 |
| Date Added to Maude | 2009-10-19 |
| 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 | RESIUS 190 XPRES |
| Generic Name | IMAGING PLATE, COMPUTED RADIOGRAPHY |
| Product Code | IWZ |
| Date Received | 2009-10-13 |
| Returned To Mfg | 2007-09-01 |
| Model Number | RESIUS 190 XPRESS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KONICA-MINOLTA MEDICAL IMAGING USA, INC. |
| Manufacturer Address | 411 NEWARK POMPTON TURNPIKE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-13 |