MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Model Number	72204668
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed no problems.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.
Event or Problem Description
It was reported that the 660 hd unit froze up.The unit was restarted and nothing changed.No patient injury was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the 660 hd unit froze up and visualization was lost.The unit was restarted and nothing changed.Procedure was completed with a back-up device.No patient injury was reported.

• Brand Name: SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM
• Common Device Name: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7489093
• Report Number: 1643264-2018-00341
• Device Sequence Number: 1313870
• Product Code: LMB
• UDI-Device Identifier: 00885556623695
• UDI-Public: (01)00885556623695
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72204668
• Device Catalogue Number: 72204668S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1