MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UHD 4K FLAT PANEL DISPLAY LCD SONY 31\"; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72205011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the monitor was unusual heated after an hour of use.
Additional Manufacturer Narrative
There was no relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A power supply serial number (b)(4) was returned with the monitor.A functional test revealed that the unit performed as expected.A review of the device history record for serial number (b)(4) showed that this unit passed all acceptance criteria and was compliant upon release for distribution in (b)(6) of 2017.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies upon release into distribution.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event include comparison to smaller monitors which may run cooler.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.

• Brand Name: UHD 4K FLAT PANEL DISPLAY LCD SONY 31\"
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7242322
• Report Number: 1643264-2018-00106
• Device Sequence Number: 1177370
• Product Code: GCJ
• UDI-Device Identifier: 04548736013940
• UDI-Public: (01)04548736013940
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: IN
• PMA/510(K) Number: K150377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2018

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: 72205011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 03/06/2018; 09/12/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/08/2018; 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1