MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-19 for MERGE EYE STATION MERGE EYE STATION V11.5 manufactured by .
[80640890]
Merge healthcare is continuing to investigate the customer's allegation. With the canon camera not yet being returned to the user facility, the investigation is pending. When additional investigation information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[80640911]
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)2017, merge healthcare received information regarding images appearing dark. No other information was provided. Follow up was completed and on 07/19/2017, merge healthcare received additional information indicating that the camera had to be sent to canon for repair and has not been received back by the account. According to the information received, patients were being rescheduled until the camera could be returned. 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 diagnosing and procedures. No patient harm has been reported at this time. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2017-00153 |
| MDR Report Key | 6727251 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-07-19 |
| 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 | MRS. MEG MUCHA |
| Manufacturer Street | 900 WALNUT RIDGE DRIVE |
| Manufacturer City | HARTLAND, WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 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 | 2017-07-19 |
| Returned To Mfg | 2017-11-08 |
| Model Number | MERGE EYE STATION V11.5 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |