CHART SMART: Documenting known or suspected medical device failure

July 2004 
Volume 34  Number 7
Pages 28 - 28
  PDF Version Available!


  • What do I need to do?

  • Who files the FDA report?

  • Critical information

    MEDICAL DEVICES include everything from tongue blades to magnetic resonance imaging machines to implanted heart valves. A suspect medical device is one that may be defective or may have malfunctioned, causing or contributing to an adverse event. Whether or not the suspect medical device injures a patient or caregiver, the problem must be reported.

    The Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, also known as MedWatch, includes a section for reporting known or suspected medical device failures. Forms and instructions are available at . You can also make MedWatch reports by phone, fax, or mail.

    What do I need to do?

    If you know or suspect that a device is malfunctioning or defective, take it out of service. If the device has electronic ...

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