MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 4K UHD LCD MONITOR

Model Number OEV321UH

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, lcd panel failure.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, they found image artifacts on the lcd panel.This complaint is most likely the result of lcd panel failure.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that a vertical or horizontal line on the image was visible even without input signal.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing, it was found that the image issue was due to lcd panel failure.This report is being submitted for the malfunction found during evaluation (lcd panel failure).

• Brand Name: 4K UHD LCD MONITOR
• Type of Device: MONITOR
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16865020
• MDR Text Key: 314858240
• Report Number: 3002808148-2023-04512
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170418723
• UDI-Public: 04953170418723
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K220069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

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
• Device Operator: Health Professional
• Device Model Number: OEV321UH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1