MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for ICONNECT ENTERPRISE ARCHIVE ICONNECT ENTERPRISE ARCHIVE V11.1.2 manufactured by Merge Healthcare.
[81431681]
Merge healthcare is continuing to investigate and evaluate the customer's allegation that images were not available for the patient. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[81431682]
(b)(6) is a web-based solution that provides a conduit for a piece of software to reach the greatest number of platforms. The system is designed to provide workflow integration capabilities for healthcare enterprises. On 06/26/2017, merge healthcare received information that images were not available for a patient. Additional information was received from the account on 07/24/2017 that indicated the inability to view images impacted the patient's care. A procedure was delayed due to the inability to view previously acquired images. The patient was re-imaged and the procedure was completed without issue. With images not being available for viewing as expected, there is a potential for harm due to a delay in treatment. The customer indicated that no direct patient harm occurred as a result of the delayed procedure. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00160 |
| MDR Report Key | 6745980 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-07-24 |
| Device Manufacturer Date | 2016-06-17 |
| Date Added to Maude | 2017-07-26 |
| 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 | MRS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| 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 | HARLTAND, 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 | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-07-26 |
| Model Number | ICONNECT ENTERPRISE ARCHIVE V11.1.2 |
| 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 | 2017-07-26 |