MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-13 for SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM 72204668S manufactured by Smith & Nephew, Inc..
[108239891]
Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[108239892]
It was reported that the unit crashed halfway through the surgery, the customer could not get this up and running again until it left theatre. There was no backup device available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2018-00364 |
| MDR Report Key | 7509691 |
| Date Received | 2018-05-13 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-05-13 |
| 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 |
| 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 | SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2018-05-13 |
| Returned To Mfg | 2018-06-18 |
| Catalog Number | 72204668S |
| 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 | 2018-05-13 |