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

Model Number	72204668S
Medical Device Problem Codes	Overheating of Device (1437); Output below Specifications (3004); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that the image management system fan was very loud, also did not have analog output, was overheating and freezing.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of the device and no deficiencies were observed.A functional test revealed that the analog video outputs are not working.The fan noise was not loud but was normal.Internal thermal related issues were observed.When warmed up, the device could not recognize the video input card and the shutdown function does not complete.The device case/surface temperature was not overheating to the touch, or to the point of a risk of burn/injury.It was determined the device contributed to the reported events of an analog output issue, and the overheating and freezing issues.The complaint was confirmed and the root cause was associated with component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include thermal sensitivity of components.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded noise was a repeat issue.The analog output issue, and the overheating and freezing issues were found to be isolated events.A risk management review found that the reported failures were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12872889
• Report Number: 1643264-2021-02426
• Device Sequence Number: 19274071
• Product Code: LMB
• UDI-Device Identifier: 00885556630082
• UDI-Public: 00885556630082
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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 Model Number: 72204668S
• Device Catalogue Number: 72204668S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown