MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-29 for SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM 72204668S manufactured by Smith & Nephew, Inc..
[134444521]
Patient Sequence No: 1, Text Type: N, H10
[134444522]
It was reported that the device had to be reset during mid case. No patient injury or significant delay were reported. Unknown if there was a back up device available.
Patient Sequence No: 1, Text Type: D, B5
[138779019]
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 exterior of product and no damage was observed. Complaint of resetting during performance was confirmed. Unit did fail intermittently during boot up with error message. The error could be caused if the system stopped responding, crashed, or lost power unexpectedly. Product successfully booted up with a known good hdd installed. The complaint investigation has concluded the cause of the failure to be a software error and hdd needs to be recloned. 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
[138779020]
It was reported that, during a knee arthroscopy, the device had to be reset mid case. There was not a back-up device available to complete the procedure. It is unknown how the procedure was finished. Neither significant delay nor patient injury were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2019-00077 |
| MDR Report Key | 8287251 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-29 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-01-29 |
| 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 Phone | 5123585706 |
| 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 | 2019-01-29 |
| Returned To Mfg | 2019-01-29 |
| 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 | 2019-01-29 |