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

Catalog Number 66801280

Device Problem Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Event Description

It was reported that npwt device has become too hot.Device was wrapped in bath towel, patient himself hyperactive, restless by his dementia.The npwt wound was very after the ileo-stom opening.No patient impact reported.The treatment was continued with a back-up device.

Manufacturer Narrative

Our investigation into the complaint has now concluded.The device was sent to our technical centre so a thorough technical analysis could be carried out to help to identify if there were any problems and/or what could have caused the reason for the complaint.A visual inspection of the device found the back enclosure was broken.Further functional evaluations were conducted however the complaint issue of overheating could not be replicated or confirmed.A performance and safety check was conducted and no anomalies or problems were found, the device passed all functional tests and was confirmed working within specifications.Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8219954
• MDR Text Key: 132207878
• Report Number: 8043484-2019-00017
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Device Lot Number: KTAG160426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1