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 5.35.5 manufactured by Merge Healthcare.
[38228043]
Upon retrospective review, this issue was determined to be reportable as an mdr. Engineering has evaluated and assessed this device malfunction. A fix has been implemented in version 9. 4. 4. 1.
Patient Sequence No: 1, Text Type: N, H10
[38228044]
Iconnect enterprise archive a vendor neutral archive for storage and communications of medical images and data. A customer called to inform merge healthcare that an error message is displaying while reading a ct scan. The error message is preventing the radiologists from comparing the ct studies with priors. This event can impact patient care since the radiologists need to have results for stroke alerts within 45 minutes. The radiologists are having to reboot the pc to clear this error. The customer did not report a serious injury to the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2016-00001 |
| MDR Report Key | 5437789 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-16 |
| Date of Report | 2016-02-15 |
| Date of Event | 2015-11-15 |
| Date Mfgr Received | 2015-11-15 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2183926-02/15/2016-067-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICONNECT ENTERPRISE ARCHIVE |
| Generic Name | IMAGE ARCHIVE |
| Product Code | LMB |
| Date Received | 2016-02-16 |
| Model Number | 5.35.5 |
| 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 |