MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-07 for IMAGE MANAGEMENT SYSTEM 660HD-E 72204668 manufactured by Smith & Nephew, Inc..
[85583612]
Patient Sequence No: 1, Text Type: N, H10
[85583613]
It was reported the 660hd image management system overheated. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[135412283]
There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the exterior of product and no physical damage was observed. Product did not overheat during functional testing. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2017-00523 |
| MDR Report Key | 6849586 |
| Date Received | 2017-09-07 |
| Date of Report | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-09-07 |
| 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 W. 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 | IMAGE MANAGEMENT SYSTEM 660HD-E |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-09-07 |
| Returned To Mfg | 2017-08-29 |
| Model Number | 72204668 |
| Catalog Number | 72204668 |
| 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 | 2017-09-07 |