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 Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Event Description

It was reported that the device turns on and then the controls don¿t work anymore, it freezes.No harm or injury reported.

Manufacturer Narrative

H10.H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection reported no defects.The functional evaluation confirmed that the device was unable to start and operate correctly, establishing a relationship with the event reported.The root cause was identified as a failed main circuit board.A review of manufacturing records for the reported serial number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.A complaint history for the reported events has been reviewed revealing further instances in the past three years.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 DEVICE & POWER SUP
• 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
• MDR Report Key: 10374136
• MDR Text Key: 201893005
• Report Number: 8043484-2020-02301
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111155092
• UDI-Public: 4582111155092
• 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: 10/31/2020

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: 66801280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1