Aim. Medical device-related adverse events are often ascribed to ââ?¬Å?deviceââ?¬Â or ââ?¬Å?operatorââ?¬Â failure although there are more complex\ncauses. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes.\nMethod. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was\nexplored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework\nof causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each\naspect having detailed subdivisions.The approach was applied to incidents fromthe literature and an anonymous incident database.\nResults.The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of\nââ?¬Å?device,ââ?¬Â ââ?¬Å?operator,ââ?¬Â or ââ?¬Å?infrastructureââ?¬Â failures. Applied to incident databases it suggested that causes differ between device types\nand identified the causes of device unavailability. Discussion.The structured approach enables digging deeper to uncover the wider\ncauses rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology\nfor describing and sharing information on the causes of medical device adverse events.
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