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

Catalog Number	72204668S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had to be reset during mid case.No patient injury or significant delay were reported.Unknown if there was a back up device available.
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 exterior of product and no damage was observed.Complaint of resetting during performance was confirmed.Unit did fail intermittently during boot up with error message.The error could be caused if the system stopped responding, crashed, or lost power unexpectedly.Product successfully booted up with a known good hdd installed.The complaint investigation has concluded the cause of the failure to be a software error and hdd needs to be recloned.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 a knee arthroscopy, the device had to be reset mid case.There was not a back-up device available to complete the procedure.It is unknown how the procedure was finished.Neither significant delay nor patient injury were reported.

• Brand Name: SVC REPL 660HD-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: 8287251
• Report Number: 1643264-2019-00077
• Device Sequence Number: 1991198
• Product Code: LMB
• UDI-Device Identifier: 00885556630082
• UDI-Public: 00885556630082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 72204668S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1