MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-02 for MERGE UNITY PACS UNITY PACS R11.2.2 manufactured by Merge Healthcare.
[145617344]
Merge unity pacs is designed to display a message to the user when an exam report fails to upload to the image server. In this instance, there was no evidence that the physician received the message warning that the report did not upload. It was not possible to determine if the message displayed on the screen for the physician when the report was first read and saved. The merge healthcare unity investigation showed the report did not upload successfully, and will have to be recreated. To resolve this issue, the exam was re-read by the doctor. No other review/investigation will be performed for cause.
Patient Sequence No: 1, Text Type: N, H10
[145617345]
Merge unity pacs is a medical image and information management system that is used for viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. On (b)(6) 2019 the customer reported an exam was read on (b)(6) 2019, however, the workstation had an operating system failure and the exam report could not be found. An investigation showed the report did not upload successfully. The report word template was created and the exam was re-read by the doctor on the same day (b)(6) 2019. There was no reported adverse event to the patient. However, while images are available, a finalized report not being available for subsequent review by the patient's physician could potentially result in a delay in care that could lead to harm. Reference complaint-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2019-00019 |
| MDR Report Key | 8573091 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-05-02 |
| 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 | MEG MUCHA |
| 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 | 3 |
| Brand Name | MERGE UNITY PACS |
| Generic Name | PICTURE AND ARCHIVING COMMUNICATIONS SYSTEM |
| Product Code | LLZ |
| Date Received | 2019-05-02 |
| Model Number | UNITY PACS R11.2.2 |
| Operator | HEALTH PROFESSIONAL |
| 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 DRIVE HARTLAND WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |