MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-16 for ICONNECT ENTERPRISE ARCHIVE V9.4.3 manufactured by Merge Healthcare.
[38219530]
Upon retrospective review, this issue was determined to be reportable as an mdr.
Patient Sequence No: 1, Text Type: N, H10
[38219531]
An iconnect enterprise archive customer reported that reports are not matching/reconciling after name change. Customer further explained if a trauma patient comes in and patient information is not available immediately, patient is stored under doe patient. When the report is being transcribed as trauma and patient has been discharged, the report type does not match the study after the name change. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2015-00162 |
| MDR Report Key | 5437913 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-11-16 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 2015-06-25 |
| Date Added to Maude | 2016-02-16 |
| 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 RD |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| 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 | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATION SYSTEM |
| Product Code | LMB |
| Date Received | 2016-02-16 |
| Model Number | V9.4.3 |
| 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 | 2016-02-16 |