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 Failure to Charge (1085)

Patient Problem Perforation of Esophagus (2399)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

It was reported that during use the console does not charge at all.No patient harm was reported.

Manufacturer Narrative

Our investigation into the complaint has now concluded.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.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.During functional evaluation of the device the complaint issue of failure to charge was confirmed as the battery would not fully charge.The cause of this was identified as a faulty battery.Following the complaint assessment suitable repairs were conducted and the device was tested and confirmed working within expected parameters.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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8139036
• MDR Text Key: 129582269
• Report Number: 8043484-2018-00427
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1