MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UHD 4K FLAT PANEL DISPLAY LCD SONY 31"; DEVICE, GENERAL MEDICAL

Model Number	LMD-X310MD
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is under evaluation by the manufacturing site.
Event or Problem Description
It was reported that the sony monitor was not turning on.The display was black.No case reported; therefore, there was no patient involvement.Preliminary results of investigation have concluded that he the device does not display an image which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h3, h6.The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional test revealed that the monitor powers up but does not display an image.The complaint was verified and the root cause was associated with an electrical problem.Factors that may have contributed to the reported event include a failed video board.A complaint history review concluded this was a repeat issue.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: UHD 4K FLAT PANEL DISPLAY LCD SONY 31"
• Common Device Name: DEVICE, GENERAL MEDICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10383083
• Report Number: 1643264-2020-00796
• Device Sequence Number: 13745101
• Product Code: LDQ
• UDI-Device Identifier: 04548736013940
• UDI-Public: 04548736013940
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1