MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-02 for MERGE CARDIO MERGE CARDIO V10.2 P1 AND P2 manufactured by Merge Healthcare.
[145617137]
At this time this issue is still being investigated by merge healthcare, when more information becomes available a supplemental will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145617138]
Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. On (b)(6) 2019, a customer alleged that clinical reporting was logging off without saving previously entered report data. This could lead to a delay in patient care while redoing the clinical report. Delay in treatment has a potential to lead to harm. However, there is no allegation of harm to a patient as a result of this issue. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2019-00020 |
| MDR Report Key | 8573177 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2016-09-22 |
| 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 | MS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DR. |
| 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 CARDIO |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS AND WORKSTATIONS |
| Product Code | LLZ |
| Date Received | 2019-05-02 |
| Model Number | MERGE CARDIO V10.2 P1 AND P2 |
| 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 | 2019-05-02 |