Medical device manufacturer, Terumo Cardiovascular Systems Corporation, has issued a field safety notice on the use of CDI™ Blood Parameter Monitoring System 500.
The manufacturer identified that contact between the power cables and the sharp edge of the chassis can potentially damage the cables' insulation. This could result in an electrical short, which could further create sparking, fire, smoke, shock or monitor failure. There have been no reports of occurrence of this issue or patient injury as a result of this issue.
According to the local supplier, the affected product is distributed in Hong Kong. If you are in possession of the product, please contact your supplier for necessary actions.