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

Catalog Number 66801281

Device Problem False Alarm (1013)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that during npwt utilizing renasys touch, the message of blockage alarm was displayed on the screen.The problem was solved by exchanging the device with a competitor device.There was no delay.There was no patient harm.The device will be returned to jp local service for evaluation.The results will be shared after its completion.

Manufacturer Narrative

The device, was used in treatment was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.No serial number was provided , a dhr review could not be performed.A complaint history review was performed for the product and failure mode reported, there have been further instances.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.Probable root cause maybe a component failure.This investigation is now complete with no further action deemed necessary.Smith + nephew 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: 10800214
• MDR Text Key: 215006999
• Report Number: 8043484-2020-03784
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111155924
• UDI-Public: 4582111155924
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801281
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention