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FDA Tracking Requirements
9650-001355-01 Rev. M
X Series Operator’s Guide
1-25
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:
+1-978-421-0025
Telephone: +1-978-421-9655
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.
Summary of Contents for X Series
Page 1: ...Includes Real CPR Help and See Thru CPR X Series Operator s Guide 9650 001355 01 Rev M...
Page 64: ...Chapter 2 Product Overview 2 24 www zoll com 9650 001355 01 Rev M...
Page 74: ...Chapter 3 Monitoring Overview 3 10 www zoll com 9650 001355 01 Rev M...
Page 80: ...Chapter 4 Trends 4 6 www zoll com 9650 001355 01 Rev M...
Page 90: ...Chapter 5 Alarms 5 10 www zoll com 9650 001355 01 Rev M...
Page 110: ...Chapter 7 Monitoring Respiration Resp and Heart Rate HR 7 10 www zoll com 9650 001355 01 Rev M...
Page 126: ...Chapter 8 Monitoring Non Invasive Blood Pressure NIBP 8 16 www zoll com 9650 001355 01 Rev M...
Page 156: ...Chapter 10 Pulse CO Oximetry SpO2 10 18 www zoll com 9650 001355 01 Rev M...
Page 166: ...Chapter 11 Monitoring Invasive Pressures IBP 11 10 www zoll com 9650 001355 01 Rev M...
Page 198: ...Chapter 14 12 Lead ECG Interpretive Analysis 14 16 www zoll com 9650 001355 01 Rev M...
Page 218: ...Chapter 16 Advisory Defibrillation 16 6 www zoll com 9650 001355 01 Rev M...
Page 224: ...Chapter 17 Analysis CPR Protocol Defibrillation 17 6 www zoll com 9650 001355 01 Rev M...
Page 234: ...Chapter 18 External Pacing 18 10 www zoll com 9650 001355 01 Rev M...
Page 242: ...Chapter 19 Real CPR Help 19 8 www zoll com 9650 001355 01 Rev M...
Page 254: ...Chapter 21 Patient Data 21 6 www zoll com 9650 001355 01 Rev M...
Page 338: ...Specifications A 38 www zoll com 9650 001355 01 Rev M...