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 2018-06-27 for MERGE EYE STATION MERGE EYE STATION 11.5 manufactured by Merge Healthcare.
[112736788]
Based on follow-up information from the customer, the replacement of the motherboard on the desktop computer resolved the issue. The customer's merge eye station account has been active since 2006 and there are no previous service records indicating that a workstation motherboard was serviced. No further investigation or action required.
Patient Sequence No: 1, Text Type: N, H10
[112736789]
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 a merge eye station was unable to boot at start-up. Support determined the hard drives would need to be replaced and on (b)(6) 2018, the hard drives were shipped. Dell support also performed an investigation and determined the issue was related to the motherboard of the pc. On 06/25/2018, additional information was received from the account. According to the new information, the issue impacted patient care, as patients had to be rescheduled two(2) weeks out. This issue is being reported due to the potential for harm related to the inability of the eye care professional to obtain the necessary information for procedures. No patient harm was reported as a result of this issue. Reference complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00053 |
| MDR Report Key | 7643081 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-27 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2018-06-27 |
| 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 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 | 2018-06-27 |
| Model Number | MERGE EYE STATION 11.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-06-27 |