MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-06 for IMAGE MANAGEMENT SYSTEM 660HD-E 72204668 manufactured by Smith & Nephew, Inc..
[72132352]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72132353]
It was reported the screen went black on the image management system 660hd-e. This occurred during the procedure. A backup device was readily available. There were no delays or patient injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[74732502]
Device investigation narrative - complaint of blank screen could not be reproduced. Unit passed functional testing during 6 hour burn-in including touchscreen functions and capturing video stills and clips. Display remained constant throughout functional testing and burn-in. All video inputs/outputs normal and unit's software performed as expected. Unit was tested in both pal and ntsc formats and both analog and digital video outputs. No problem found. A review of the device history record for serial number (b)(4) shows that this unit passed all acceptance criteria and was compliant upon release for distribution on february of 2017. No containment or corrective actions are recommended at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2017-00190 |
| MDR Report Key | 6464992 |
| Date Received | 2017-04-06 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-05-03 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2017-04-06 |
| 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 | 3 |
| Brand Name | IMAGE MANAGEMENT SYSTEM 660HD-E |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2017-04-06 |
| Returned To Mfg | 2017-04-10 |
| 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 | 2017-04-06 |