MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-27 for MERGE EYE STATION MERGE EYE STATION V11.4 manufactured by Merge Healthcare.
[89419882]
This intermittent and ongoing customer issue continues to be investigated by merge healthcare. When additional information becomes available a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[89419883]
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 08/1/2017, merge healthcare received information from an account regarding a database connection failure on the eye station. Merge healthcare technical support evaluated the customer's device and made some adjustments based on their system and the software/network environment. However, the customer reported that the issue was continuing to happen intermittently at a later date. To attempt to resolve the customer's database connection errors, merge healthcare technical support has reconfigured a directory, disabled real time scanning, and changed a setting on a network card. Additional information was received from the customer on 09/27/2017 that indicated patients had to be rescheduled and had to receive injections of fluorescein again because images were lost. This issue is being reported due to the potential for harm related to the delay in the inability of the eye care professional to obtain the necessary information for procedures in a timely manner and for reinjection of the fluorescein dye into the patient. The customer has not reported that any patient harm occurred as a result of this issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00182 |
| MDR Report Key | 6899835 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-27 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-09-27 |
| 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 |
| 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 | HARLTAND, 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 | 2017-09-27 |
| Model Number | MERGE EYE STATION V11.4 |
| 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 HARLTAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-27 |