MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-04-20 for MERGE EYE STATION MERGE EYE STATION 11.4 manufactured by Merge Healthcare.
[106147769]
The customer returned the cameras to merge healthcare for evaluation. The hardware has been forwarded to the vendor/supplier for further investigation. When additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[106147770]
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 an account was receiving error communication codes when trying to use the camera. After switching out cables and investigating, merge healthcare technical support determined the camera needed to be returned for repair. On 04/10/2018, additional information was received from the customer. According to the information received, the issue impacted patient care as information could not be obtained for diagnosis and treatment. 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. No patient harm was reported as a result of this issue. Reference complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183926-2018-00024 |
| MDR Report Key | 7449381 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-22 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-04-10 |
| Date Added to Maude | 2018-04-20 |
| 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 |
| 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 | 2018-04-20 |
| Returned To Mfg | 2018-03-29 |
| Model Number | MERGE EYE STATION 11.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERGE HEALTHCARE |
| Manufacturer Address | 500 WALNUT RIDGE DR. HARTLAND, WI 53029 US 53029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-20 |