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 2018-07-21 for MERGE EYE STATION MERGE EYE STATION V. 11.5.1 manufactured by Merge Healthcare.
[114701380]
During the installation, the customer was testing the system to compare with their facility requirements/codes. The customer's allegation about micro amps exceeding their facility requirements is being investigated by merge healthcare. The device is being returned to merge healthcare. Once the device is investigated and additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[114701381]
Merge eye station is intended to be used in conjunction with existing ophthalmic fundus cameras to take images of the eye, perform fluorescein angiography, red free, color and icg still-image photography as well as video imaging. On (b)(6) 2018, merge healthcare was notified that during installation of a merge eye station/capture system, that the electrical output was found to exceed the customer's facility code for micro amps. The device was unused by the customer or patients due to this being a new installation. Merge healthcare is working with the customer to investigate their facility, their codes and the interaction of the merge eye station. This issue is being reported due to the potential for harm due to a system configuration that exceeded the customer's facilities code. No patient harm has been reported as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00067 |
| MDR Report Key | 7709372 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-21 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2018-07-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 DRIVE |
| 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 EYE STATION |
| Generic Name | CAMERA, OPHTHALMIC, AC-POWERED |
| Product Code | HKI |
| Date Received | 2018-07-21 |
| Model Number | MERGE EYE STATION V. 11.5.1 |
| 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 | 2018-07-21 |