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

Model Number	LMD-2760MD
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after the procedure, a partially raw cable of the "sony 27 monitor" caused an electrical shock to a nurse that touched the support of the monitor.In consequence, she had to be supported by hospital first aids.No 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.There was a relationship found between the returned device and the reported incident.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.A complaint history review concluded this was an isolated event.An analysis of the customer provided images found that the power cord jacket is damaged exposing shielding.A review of the instructions for use found the socket-outlet shall be installed near the equipment and shall be easily accessible.A review of risk management files found that the reported failure was documented appropriately.Clinical evaluation found that no further medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include inadvertent stress applied to the cable.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.No containment or corrective actions are recommended at this time.

• Brand Name: SONY 27 MONITOR
• 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: 10241014
• Report Number: 1643264-2020-00481
• Device Sequence Number: 16879345
• Product Code: GCJ
• UDI-Device Identifier: 04905524983111
• UDI-Public: 04905524983111
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LMD-2760MD
• Device Catalogue Number: 72204860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention