he Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Arkon Anesthesia Delivery System [Model Number: 99999 (230 VAC versions)], manufactured by Spacelabs Healthcare.
The manufacturer has received two reports of the Arkon transformer inrush PCBA (PN: 670-1624-00) failing prematurely and causing loss of power on all auxiliary power outlets. The failure mode requires the cumulative auxiliary power outlet load to be in excess of 200 watts. If the inrush PCBA fails, Anesthesia monitoring, alarming and ventilation delivery will not be affected.
According to the manufacturer, the potential risk is that devices which do not have battery backup and that are plugged into an auxiliary outlet may lose power.
The manufacturer advises affected users to weigh the benefits versus the risks as well as ability to deploy alternative devices when deciding whether or not to continue to use the system. If users continue to use the affected system, the manufacturer advises the following:
The manufacturer would replace the affected transformer inrush PCBA.
For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-21-to-25-september-2015
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 September 2015