TECH BULLETIN 06-002

REPORTING SERIOUS INCIDENTS

1.1 Initial Information

Product: All IDC systems
Priority: High
Issue Date: November 16, 2006
Units Affected: Not Applicable

1.2 Issue Resolution

The purpose of this bulletin is to educate IDC dealers and service personnel of what a
serious reportable incident is and what should be done if one occurs.

Imaging Dynamics Company • November 16, 2006 • Technical Bulletin 06-002

 1 - 2 • Resolution Description

1.3 Revision History

Revision Number Revision Date Details

0 September 29, 2006 Draft Creation.

1.0 November 16, 2006 Technical Bulletin Released

1.4 Resolution Description

A serious incident occurs when equipment sold by Imaging Dynamics has failed in such a
manner that death or serious injury did, or could have occurred. This not only includes
equipment manufactured by IDC but also equipment manufactured by one of our OEM
partners and sold as IDC equipment. In most cases these incidents are not attributed to our
detector technology, but instead a result of incorrect installation of the heavy equipment used
for positioning, such as C-arms, tube mounts or collimators. Regardless of who is at fault,
IDC MUST take certain legally required actions when we are informed of an incident in
which someone was injured or which MIGHT lead to injury if it reoccurred. Depending on the
severity of the incident, we may have only a day or two to notify regulatory authorities.
It has become clear that not everyone understands what constitutes a serious incident or
understands the proper procedures to follow when a serious incident occurs. A serious
incident does not have to involve an actual injury. If, by good chance, no one is injured when
a system falls, it is still a serious incident. Injury could have resulted and likely would, if the
system failure reoccurred.
You must be very clear about what to do if you become aware of a serious reportable incident.
You must notify, clearly and explicitly, your IDC contact, who will notify his manager and the
IDC Quality Department. You must also notify the Director of Quality, by phoning (403) 251-
9939 or phoning toll-free 1-866-XPLORER (1-866-975-6737) and asking for the Director of
QA or someone in the Quality Department. You should also notify your manager. In this
manner, awareness of the incident spreads quickly to senior staff, who will ensure a proper
response. Sending an e-mail (service@imagingdynamics.com) or putting a note in the
tracking system is a good thing to do but it is not enough. You need to be absolutely sure that
the relevant people know about the incident immediately.
Finally, it should be clear why this is so important. Reporting serious incidents is not only for
liability or regulatory compliance reasons. The first and foremost responsibility of IDC is to
ensure the safety and well being of our patients, our customers and our staff. We must not
allow this to be compromised.
Please ensure all personnel working on IDC equipment are notified about this important
bulletin. This bulletin is downloadable through the tracking site under the project of IDC –
Service Technical Bulletins.

Imaging Dynamics Company • November 16, 2006 • Technical Bulletin 06-002

 Materials and Tools • 1-3

1.5 Materials and Tools

N/A

1.6 Safety Considerations

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1.7 Work Instructions

N/A

Imaging Dynamics Company • November 16, 2006 • Technical Bulletin 06-002