MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UHD 4K FLAT PANEL DISPLAY LCD SONY 31"; ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT

Model Number	LMD-X310MD
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the panel display power up, the led lights illuminated a couple of minutes but the display had no image.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records conducted by the original equipment manufacturer confirmed that all manufacturing specifications as set out in the device master record (dmr) were met prior to its release and no issues recorded.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: UHD 4K FLAT PANEL DISPLAY LCD SONY 31"
• Common Device Name: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10310956
• Report Number: 1643264-2020-00655
• Device Sequence Number: 3065032
• Product Code: PEA
• UDI-Device Identifier: 04548736013940
• UDI-Public: 04548736013940
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: LMD-X310MD
• Device Catalogue Number: 72205011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1