MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for RFB 660 HD-E IMAGE MANAGEMENT SYSTEM 72204668F manufactured by Smith & Nephew, Inc..
[140887720]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140887721]
It was reported that the device is found unsatisfactory due loss of hdsdi video signal. A fine vertical line covering the whole entire display screen after around 10-15 minutes of still and video capturing. , disabling the application screen. There was a completely loss of image. A backup device was available to complete the procedure successfully, with no significant delay and no patient injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2019-00243 |
| MDR Report Key | 8478094 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-04-03 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RFB 660 HD-E IMAGE MANAGEMENT SYSTEM |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-04-03 |
| Catalog Number | 72204668F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |