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

Catalog Number	72204668
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the 660hd-e image management system had found unsatisfactory due to loss of hdsdi video signal.A fine vertical line covering the whole entire display screen after 5-15 min of still and video capturing, disabling the application screen of 660hd-e ims.Possible defective video capture card.30 minutes delay and a back up was available to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
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.Customer supplied images show a line pattern on the monitor in use, confirming the reported event.Complaint of hdsdi video output/input malfunction could not be reproduced.Product passed functional testing and 6 hour burn in in enclosed test tower.All video output/inputs perform as expected.Hdsdi video output/input malfunction did not occur during functional testing and the device passed all functional tests with no faults or errors.The root cause was not associated with a failure of the returned unit.Factors that could have contributed to the reported failure include a defective hd sdi cable, a faulty monitor, or another issue with the system set up.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: IMAGE MANAGEMENT SYSTEM 660HD-E
• 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: 8795834
• Report Number: 1643264-2019-00481
• Device Sequence Number: 19361727
• Product Code: LMB
• UDI-Device Identifier: 00885556623695
• UDI-Public: 00885556623695
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Catalogue Number: 72204668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1