The device used in treatment was not returned.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 and similar instances have been recorded in the previous five years, failures reported are under constant review to monitor for adverse trends.The attention ¿ inactive alarm shows and indicator illuminates solid yellow when the device has been left in standby mode for longer than 15 minutes.To enable therapy the user needs to select pressure setting and start therapy.Without the return of the actual product our investigation of this report is inconclusive.We have been unable to confirm the reported failure and subsequently determine a root cause.No further actions by smith and nephew are deemed necessary at this stage.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.In parallel we continue to monitor for any adverse trends relating to this product range.Please be assured that all products are released to market following rigorous quality checks during production and prior to dispatch.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.
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