MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-15 for MERGE EYE STATION manufactured by Merge Healthcare.
[64920186]
According to information received from the support department, the hard drives have been replaced by the manufacturer of the computer. It is unknown at this time what repairs are needed to resolve the issue. Merge healthcare continues to work with the customer to investigate the issue in order to ensure that the customer's issue is resolved.
Patient Sequence No: 1, Text Type: N, H10
[64920187]
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) 2016, merge healthcare received information from a customer indicating that a system was locking up. A reboot of the system corrected the lock but the system continued to lock up throughout the day. The customer requested the system be returned and repaired and requested a loaner for use in the interim. Information received on 12/21/2016, from the customer, indicates the issue impacted patient care. Additional information received on "01/06/2016" indicates the issue is ongoing, despite assistance from merge healthcare support. The customer stated the issue is becoming worse, leading to a delay in patient studies and pictures. This issue is being reported due to the potential for harm related to the delay in patient studies and pictures. Additional information regarding direct patient impact has been requested but not received. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00014 |
| MDR Report Key | 6252894 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-15 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2017-01-15 |
| 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 DRIVE |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2629123570 |
| Manufacturer G1 | MERGE HEALTCHARE |
| 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 | 2017-01-15 |
| Lot Number | K913929 |
| 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 | 2017-01-15 |