MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-22 for MERGE EYE CARE PACS MERGE EYE CARE PACS 5.3.1 manufactured by Merge Healthcare.
[136854861]
Merge healthcare is continuing to investigate the customer's reported issue. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136854862]
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) 2019, merge healthcare received information from an account regarding incorrect information pulling into patient's record. According to the information received, an eye care professional could be looking at patient data and the information will switch to the previous patient's information. This issue is being reported due to the potential for harm related to the possibility of incorrect diagnosis or treatment being administered to the wrong patient. No patient harm occurred as a result of this issue. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2019-00006 |
| MDR Report Key | 8361003 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-22 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2018-10-18 |
| Date Added to Maude | 2019-02-22 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123514 |
| 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 | 3 |
| Brand Name | MERGE EYE CARE PACS |
| Generic Name | SYSTEM, IMAGE MANAGEMENT, OPHTHALMIC |
| Product Code | NFJ |
| Date Received | 2019-02-22 |
| Model Number | MERGE EYE CARE PACS 5.3.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-02-22 |