MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-01 for MERGE EYE CARE PACS MERGE EYE CARE PACS V 5.2 manufactured by Merge Healthcare.
[76742213]
Merge healthcare is continuing to investigate the customer's issue to determine if additional actions are required.
Patient Sequence No: 1, Text Type: N, H10
[76742214]
Merge eye care pacs is intended to be used for viewing, communicating and storing digital images derived from an image modality. Pacs functionality includes, recording, annotating, calculations, patient medication/interaction information, monitoring & tools to modify/enhance image& demographic data. On (b)(6)2017 a merge eye care pacs customer alleged that when an image was selected for deletion another image was deleted. Merge technical support investigated the customer's issue and confirmed that the image the customer had selected was not the image that was deleted. In general, customer's have the option to resend the images from the modality. This malfunction could potentially cause a delay in diagnosis or treatment for a patient, however no actual patient harm was reported by the customer. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00112 |
| MDR Report Key | 6607094 |
| Date Received | 2017-06-01 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-06-01 |
| 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 | 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 DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer G1 | MERGE HEALTHCARE |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| 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 CARE PACS |
| Generic Name | IMAGE MANAGEMENT SYSTEM FOR OPHTHALMIC IMAGES |
| Product Code | NFJ |
| Date Received | 2017-06-01 |
| Model Number | MERGE EYE CARE PACS V 5.2 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 900 WALNUT RIDGE DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |