Fda Tracking Requirements; Notification Of Adverse Events - ZOLL AEV Operator's Manual

G I
ENERAL NFORMATION

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners
of this ventilator must notify ZOLL Medical Corporation if this product is
received
•
lost, stolen, or destroyed
•
donated, resold, or otherwise distributed to a different organization
•
If any such event occurs, contact ZOLL Medical Corporation in writing with the following
information:
1. Originator's organization – Company name, address, contact name, and contact phone
number
Model number, and serial number of the ventilator
2.
Disposition of the ventilator (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
Date when the change took effect
4.
Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-04105
Fax: (978) 421-0007
Telephone: (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 to ZOLL Medical Corporation, and possibly to the FDA, the occurrence
of certain events.
These events, described in 21 CFR Part 803, include device-related death and serious injury or
illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation
requests to be notified of device failures or malfunctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality products.
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