N
Patient 1
ONCE THE DRIVE WAS REPAIRED BY DELL THE DEVICE WAS ABLE TO OPERATE AS EXPECTED. THE CUSTOMER'S ISSUE HAS BEEN RESOLVED.
MAUDE MDR 6927808
- MDR report key
- 6927808
- Report number
- 2183926-2017-00190
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-07
- Date received
- 2017-10-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. MEG MUCHA
- Address
- 900 WALNUT RIDGE DRIVE HARLTAND, WI 53029 US
- Phone
- 262-262-2629
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MERGE EYE STATION | CAMERA, OPHTHALMIC, AC-POWERED | MERGE HEALTHCARE | HKI | MERGE EYE STATION V11.5 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-07 | 0 |
Event Narratives#
D
Patient 1
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 FROM AN ACCOUNT REGARDING AN EYE STATION THAT WOULD NOT BOOT. MERGE HEALTHCARE TECHNICAL SUPPORT ATTEMPTED TO RESOLVE THE CUSTOMER'S ISSUE BUT THE CUSTOMER'S PC WAS NOT RESPONDING AS EXPECTED. THE CUSTOMER NEEDED TO CONTACT DELL SUPPORT TO REPLACE A DRIVE THAT FAILED. AFTER THE DRIVE WAS REPLACED, MERGE EYE STATION SUPPORT ENDURED THAT THE DEVICE WAS OPERATING AS EXPECTED. THE CUSTOMER REPORTED THAT THEIR ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2017 THAT INDICATED PATIENTS HAD TO BE RESCHEDULED DUE TO THE INABILITY TO BOOT THE EYE STATION COMPUTER. 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. THE CUSTOMER HAS NOT REPORTED THAT ANY PATIENT HARM OCCURRED AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT NUMBER (B)(4).