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

Model Number 66801496

Device Problems Noise, Audible (3273); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

It was reported that device was noisy whilst in pressure and during service evaluation was confirmed that device was not able to generate and control negative pressure.No case involved.

Manufacturer Narrative

The device, intended to be used in treatment, has been returned for evaluation.A visual inspection was performed and showed defects to the outer case.The functional inspection found that the device was noisy and could not maintain pressure, establishing a relationshiop between the device and the reported event.The root cause was identified as a defective vacuum motor.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.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 GO
• 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: 11580361
• MDR Text Key: 242676771
• Report Number: 8043484-2021-00688
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126944
• UDI-Public: 00040565126944
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66801496
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1