MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problem Electrical Power Problem (2925)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

It was reported that the device presented a battery issue: the console does not hold the charge and a "burning smell" was also reported by the medical team, it was confirmed that the device was not overheating at the moment of the malfunction.The device is available for analysis.

Manufacturer Narrative

H3, h6: the device, used in treatment, has been returned for servicing only, not fault was found with the device, as such we are unable to establish a relationship between the event report and the device.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history has been reviewed with similar instances recorded in the previous four years, which are under constant review monitoring for adverse trends.Battery failure can occur due to certain situations: 1.The lithium ion re-chargeable battery, contained within the device is subject to a limited number of charge cycles, battery failure can occur when it has reached its life expectancy.2.The renasys device is also fitted with a safety design feature, which activates when the battery detects that it has achieved a certain temperature, charging will pause.The instructions for use offer detailed guidance on steps taking with regard to charging the device.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9596147
• MDR Text Key: 175229577
• Report Number: 8043484-2020-00034
• Device Sequence Number: 1
• Product Code: OMP
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1