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

Model Number 66021496

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 283773008
• Report Number: 8043484-2022-00005
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1