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

Catalog Number 66801281

Device Problems Computer Software Problem (1112); Protective Measures Problem (3015)

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

Event Date 05/03/2020

Event Type  malfunction  

Event Description

It was reported that during npwt utilizing a renasys touch, the message of "808a" displayed on the screen.The problem was not solved by removing the device from the canister and reboot.The treatment was continued with a back-up device.There was no patient harm.There was no delay.

Manufacturer Narrative

The device, was used in treatment was returned for evaluation, could not establish a relationship between the event reported and the device.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed no fault found, 808a is the pressure test on start up, if it detects the pressure is outside the self test range, this alarm will display.No batch /lot number has been provided rendering a review of the device history not possible.A complaint history review found other related failures.Probable cause would likely be a system set up issue or an accessory component failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.

• 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: 10102796
• MDR Text Key: 193102315
• Report Number: 8043484-2020-00591
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1