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

Catalog Number 66801496

Device Problem Decrease in Pressure (1490)

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

Event Date 08/14/2020

Event Type  malfunction  

Event Description

It was reported that the device had the error 32100001 "low pressure".It is unknown which procedure was being performed.No patient harm was reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.No additional information was provided, we cannot establish a relationship between the device and the reported event or determine a root cause on this occasion.The device is equipped with high and low vacuum alarms to alert users to these events occurring during therapy, these alarms are designed to activate based on changes in pressure status detected by device, however, there are scenarios that may occur during therapy that can impact alarm functionality; ensure there are no kinks in canister tubing.Please refer to the instructions for use which offers further assistance.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event in the past years.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 GO
• 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: 10578445
• MDR Text Key: 208287933
• Report Number: 8043484-2020-02954
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111155054
• UDI-Public: 4582111155054
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1