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

Catalog Number 66801496

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Event Description

It was reported that the patient had a faulty charger and the device was not working due to failure to charge.The patient could not receive negative pressure to heal the wound.A new charger was found in the office and then driven to the customer.

Manufacturer Narrative

The device intended for use in treatment was not returned for evaluation at the time of the investigation.Due to this we have been unable to conduct a visual and functional evaluation, and we are unable to confirm a relationship between the complaint and the device.If a complaint sample becomes available, the complaint will be re-evaluated.A review of the device history record showed that the 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 upon release into distribution.Complaint history for the reported failure mode and part number has been reviewed and shown that in the previous five years there have been further instances.These instances are being monitored to determine if additional corrective or preventative actions are required.This failure mode can potentially be caused as a result of the device¿s inbuilt safety feature, inherent within numerous rechargeable devices.When the device is charging and/or in use, its temperature will naturally increase, this and other external factors such as ambient temperature and storage location can have an impact on the time it takes to charge.If the temperature of the device increases above a certain temperature, charging will pause until the temperature has reduced.Although the device will pause charging in these conditions, it will not impact on its ability to still provide negative pressure wound therapy.Once the device temperature drops the device will continue to charge.This along with further guidance is highlighted in the maintenance section of the instructions for use.This investigation has now been closed and recorded as insufficient information to determine a root cause.By acknowledging and investigating your complaint this collaboration enables us to drive our passion to continuously review, improve and steer our shared purpose of providing the best possible outcome for customer and patients.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

• 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: 9872153
• MDR Text Key: 185728152
• Report Number: 8043484-2020-00192
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1