9650-000752-01 Rev. D
ZOLL AED 3 Administrator’s Guide
v
Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical
Devices Act (SMDA) for reporting to ZOLL and possibly to the Food and Drug
Administration (FDA), the occurrence of certain events. These events, described
in 21 CFR Part 803, include device related death and serious injury or illness. In
any event, as part of our Quality Assurance Program, ZOLL should be notified of
any device failure or malfunction. This information is required to assure that
ZOLL provides only the highest quality products.
Technical Service
If a ZOLL product requires service, contact the ZOLL Technical Service
Department or the nearest ZOLL sales office or distributor:
Telephone: 1-978-421-9655
Toll free: 1-800-348-9011
Fax: 1-978-421-0010
Email: [email protected]
Have the following information available for the Technical Service
representative:
•
Serial number
•
Description of the problem
If you need to send the ZOLL AED 3 defibrillator to ZOLL Medical Corporation,
obtain a service order request number from the Technical Service
representative.
NOTE
Before sending the defibrillator and battery to ZOLL, check with your
local shipping company to see if there are any restrictions on shipping
lithium batteries.
Remove the battery pack from the defibrillator and return the AED and battery
pack in its original container (or equivalent packaging) with the service order
request number on it to the following address:
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824-4105
Attn: Technical Service Department
Summary of Contents for AED 3
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