SMDA Reportable Events

Facilities must report medical device events involving patient deaths to the FDA. Report serious injuries caused by devices or in which devices played a role to the manufacturer. The FDA requires that hospitals maintain documentation of all reportable events. Identify the person that completed the investigation and the information nsed to form an opinion about the causes of the event (Table 11.3). When reporting, use the following forms  

Protect the device, including packaging material and related parts. 

Document the equipment or device engineering and/or serial numbers. 

Notify Safety, Risk Management, and the appropriate response department Complete an incident report as required by the policies but within 24 honrs. 

The facility must file the report with the manufacturer or the FDA within 10 days. 

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