MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM 72204668S manufactured by Smith & Nephew, Inc..
[98744174]
Patient Sequence No: 1, Text Type: N, H10
[98744175]
It was reported that the device seemed to record, but when the dr went to look at it there was no image. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[120456566]
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of video clip malfunction was confirmed. Video images would cut out during recording. Distortion and interference would occur also. Playback of video clips would lock up and video image would blank out. Cause of video recording and playback is a defective video capture card. Unit passed functional testing and all video inputs and outputs normal with a known good capture card installed. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Patient Sequence No: 1, Text Type: N, H10
[135370802]
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 records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00069 |
| MDR Report Key | 7228806 |
| Date Received | 2018-01-30 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-01-30 |
| 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 | SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL |
| Product Code | LMB |
| Date Received | 2018-01-30 |
| Returned To Mfg | 2018-04-06 |
| 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 | 2018-01-30 |