MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SONY 27 4K DISPLAY; VIDEO MONITOR, MEDICAL IMAGING, COLOR

Catalog Number	72205329
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, the sony 27 4k display when connected via the dvi port, the he screen was flickering.The procedure was completed with a delay of 30 minutes or less using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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 device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.Smith+nephew is not considered the manufacturer of this device per 21 c.F.R.Part 803.3.Neither does smith+nephew have any special contractual obligations that require the company to perform an adverse event assessment for this product.

• Brand Name: SONY 27 4K DISPLAY
• Common Device Name: VIDEO MONITOR, MEDICAL IMAGING, COLOR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11694969
• Report Number: 1643264-2021-01475
• Device Sequence Number: 1388879
• Product Code: GCJ
• UDI-Device Identifier: 04548736100534
• UDI-Public: 4548736100534
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2021

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: 72205329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 08/19/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/21/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1