ZOLL R Series Monitor Defibrillator Rev J - Manual (Page 389)

FDA Tracking Requirements
9650-0912-01 Rev. K ZOLL R Series Operator’s Guide 1–19
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners
of this defibrillator 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
2. Model number, and serial number of the defibrillator
3. Disposition of the defibrillator (for example, received, lost, stolen, destroyed, distributed to
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
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.