SMITH & NEPHEW, INC. RFB 660 HD-E IMAGE MANAGEMENT SYSTEM; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
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Catalog Number 72204668F |
Device Problems
No Display/Image (1183); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that the device is found unsatisfactory due loss of hdsdi video signal.A fine vertical line covering the whole entire display screen after around 10-15 minutes of still and video capturing., disabling the application screen.There was a completely loss of image.A backup device was available to complete the procedure successfully, with no significant delay and no patient injuries reported.
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Manufacturer Narrative
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The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of hd-sdi output malfunction was confirmed.The unit failed boot up with a video card failure.The hd-sdi live video output is blank.Cause of hd-sdi output malfunction is a defective video capture card.Unit passed functional testing and all video inputs and outputs normal with a known good capture card installed.The complaint investigation has concluded that the cause of the hd-sdi output failure was caused by a defective electronic component on the video card.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.
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Event Description
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It was reported that during procedure, the device was found unsatisfactory due loss of hdsdi video signal.A fine vertical line covering the whole entire display screen after around 10-15 minutes of still and video capturing., disabling the application screen.There was a completely loss of image.A backup device was available to complete the procedure successfully, with no significant delay and no patient injuries reported.
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Search Alerts/Recalls
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