MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

It was reported that during treatment the device presented an overheating of the device.There were no consequences for the patient.

Manufacturer Narrative

H10.H3, h6: the device, used in treatment, has been returned and evaluated.The visual inspection found no defects.The functional evaluation found no fault, nor any sign of overheating.This evaluation was not able to establish a relationship between the device and the event reported.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history has been reviewed with similar instances recorded in the past three years.When the device is charging and/or in use, its temperature will naturally increase, this and other external factors such as ambient temperature and storage location can have an impact on the time it takes to charge.If the temperature of the device increases above a certain temperature, charging will pause until the temperature has reduced.This could be the reason why the device felt warm to the touch.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10314406
• MDR Text Key: 200063113
• Report Number: 8043484-2020-02158
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223494988
• UDI-Public: 5000223494988
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Device Lot Number: KTCG190724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1