MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-28 for IMAGE MANAGEMENT SYSTEM 660HD-E 72204668 manufactured by Smith & Nephew, Inc..
[109487106]
Patient Sequence No: 1, Text Type: N, H10
[109487107]
It was reported that when taking the picture the screen froze and the system shut down resulting in the loss of picture. Occurred during procedure. A back-up was available, no delay reported.
Patient Sequence No: 1, Text Type: D, B5
[115808190]
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. A relationship, if any, between the subject device and the reported event could not be determined. A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00413 |
| MDR Report Key | 7547840 |
| Date Received | 2018-05-28 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-05-28 |
| 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 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 | 2018-05-28 |
| Returned To Mfg | 2018-07-31 |
| Catalog Number | 72204668 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-28 |