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 2018-07-30 for MERGE EYE STATION MERGE EYE STATION 11.6.1. manufactured by Merge Healthcare.
[115526509]
According to the information received by the support technician, the device was found to have a defective hard drive and the hard drive was scrapped on site. Replacing the hard drive resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
[115526510]
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 hard drive failed on a merge eye station. On (b)(6) 2018, merge healthcare shipped a hard drive. On (b)(6) 2018 the hard drive was reconfigured and the system was again operational. On (b)(6) 2018, information was received from the customer indicating this issue did have impact on patient care as patients had to be rescheduled. To the account's knowledge, the issue did not result in any harm for the patient. 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00068 |
| MDR Report Key | 7733543 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-07-18 |
| Device Manufacturer Date | 2017-11-09 |
| Date Added to Maude | 2018-07-30 |
| 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 |
| Remedial Action | RL |
| 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 | 2018-07-30 |
| Model Number | MERGE EYE STATION 11.6.1. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-07-30 |