MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66021496
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during npwt, a renasys go emits an odor even though the canister was changed, it is also making a clicking noise and the back is really warm.It is unknown how treatment was resumed.No harm to the patient or further complications reported.Further information is not available.
Additional Manufacturer Narrative
The device was not returned for evaluation, all supplied information has been reviewed and we have not been able to confirm the complaint.The instruction for use detail that if a high ambient temperature is experienced the device will pause charging to prevent damage to the device, during use the device may feel warm.The odor filter is intended to be changed after every patients use, the changing of the canister does no prevent odors.The clicking noise experienced may denote a component failure, but this cannot be confirmed without evaluating the device.A documentation review has been conducted, confirmed that no manufacturing problems where observed.Previous complaints of this nature have been recorded, with no historical escalations or manufacturing problems observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.
Additional Manufacturer Narrative
While this event is no longer considered reportable, this report is being submitted as a courtesy to provide updated investigation results based on the return and evaluation of the complaint device subsequent to the submission of our previous supplemental report.The device was not returned for evaluation, all supplied information has been reviewed and we have not been able to confirm the complaint.The instruction for use detail that if a high ambient temperature is experienced the device will pause charging to prevent damage to the device, during use the device may feel warm.The odor filter is intended to be changed after every patients use, the changing of the canister does no prevent odors.The clicking noise experienced may denote a component failure, but this cannot be confirmed without evaluating the device.A documentation review has been conducted, confirmed that no manufacturing problems where observed.Previous complaints of this nature have been recorded, with no historical escalations or manufacturing problems observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: RENASYS GO
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13152361
• Report Number: 8043484-2022-00005
• Device Sequence Number: 17138412
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2022

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: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/08/2022; 02/08/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/08/2022; 07/11/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown