Notification Of Adverse Events - ZOLL SurePower Single Bay Charger Operator's Manual

Disposition of the device (for example, received, lost, stolen, destroyed, distributed to
3.
another organization), new location and/or organization (if known and different from
originator's organization) - company name, address, contact name, and contact phone
number
4. Date when the change took effect
Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-4105
Fax: (978)-421-0025
Tel: (978)-421-9655

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act
(SMDA) for reporting the occurrence of certain events to ZOLL Medical Corporation and
possibly, in the United States, to the Food and Drug Administration (FDA).
These events, described 21 CFR Part 803, include device-related death and serious injury or
illness. In any event, as part of our Quality Assurance Program, ZOLL Medical Corporation
should be notified of any device failures or malfunctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality products.
9650-000272-05 Rev. B SurePower Single Bay Charger Operator's Guide
Using this Manual
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