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

Model Number	72204668S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had the screen black.A backup device was available to complete the procedure with no delay or patient injuries.
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 no issue was observed.Complaint of blank display could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Unit did not lose display or touchscreen function during 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.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• 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: 7428851
• Report Number: 1643264-2018-00285
• Device Sequence Number: 19261637
• Product Code: LMB
• UDI-Device Identifier: 00885556630082
• UDI-Public: (01)00885556630082
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 72204668S
• Device Catalogue Number: 72204668S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1