MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for MERGE EYE STATION IMPORT UTILITY ESIU 1.0 manufactured by Merge Healthcare.
[35260606]
Upon retrospective review, this issue was determined to be reportable as an mdr. However, during internal investigation no customers in the us were identified or affected.
Patient Sequence No: 1, Text Type: N, H10
[35260607]
Information in eye station medical image dicom fields may persist inappropriately from one image to another when one or more values in the new import file are empty, since empty values in the new file are not erasing the corresponding values in the previously imported file. The issue would only present itself if these specific conditions occur: a non-mandatory field is not present in an imported dicom image after the same field in a previously imported dicom file has been present, and both files are in the same import directory. If the physician does not notice the anatomy of the retina displayed in the image and relies solely on the text on the image, there may be a remote chance that patient injury could occur due to improper treatment. There were no injuries reported due to this incident. There are no devices in the field that are likely to cause injury. An issue relating to this defect would require the following conditions to happen: esiu is setup to receive dicom files for import. A non-mandatory field is not present in an imported dicom image after the same field in a previously imported dicom file has been present and both files are in the same import directory. Note that the two images could be from the same or from different patients. (patient name cannot be mixed up as it is mandatory though). The wrong value in this field in the second image is causing a wrong diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00018 |
| MDR Report Key | 5337578 |
| Date Received | 2015-12-31 |
| Date of Report | 2015-12-30 |
| Date of Event | 2013-06-28 |
| Date Mfgr Received | 2013-06-28 |
| Device Manufacturer Date | 2013-05-23 |
| Date Added to Maude | 2015-12-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL DIEDRICK |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MERGE EYE STATION IMPORT UTILITY |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | NFJ |
| Date Received | 2015-12-31 |
| Model Number | ESIU 1.0 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DR. HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-31 |