MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB 660 HD-E IMAGE MANAGEMENT SYSTEM; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Catalog Number	72204668F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: RFB 660 HD-E IMAGE MANAGEMENT SYSTEM
• Common Device Name: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8478094
• Report Number: 1643264-2019-00243
• Device Sequence Number: 19323318
• Product Code: LMB
• UDI-Device Identifier: 00885556630099
• UDI-Public: 00885556630099
• Combination Product (Y/N): N
• 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): 05/09/2019

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: 72204668F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1