ZOLL M Series Defibrillator Rev YH - Manual (Page 19)

General Information
1-11
FDA Regulations
Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of
defibrillators. As an owner of this device, you have the
responsibility under this law to notify ZOLL Medical
Corporation if this product has been received; lost, stolen
or destroyed; or has been donated, resold, or otherwise
distributed to a different organization.
If any of the events described above occur, please
contact ZOLL Medical Corporation in writing with the
following information:
1. Originator's organization — Company Name,
Address, Contact Name, and Contact Phone Number
2. Part Number/Model Number and Serial Number
3. Disposition of Device (e.g., received, lost, stolen,
destroyed, distributed to another organization), New
Location and/or Organization (if different from #1
above) - Company Name, Address, Contact Name,
and Contact Phone Number
4. Date change took effect
5. Other information or comments
Please address your information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-4105
Fax: (978) 421-0010
Tel: (978)
421-9655
Notification of Adverse Events
As a health care provider, you may have responsibilities
under the SMDA, for reporting to ZOLL 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 any
event, as part of our Quality Assurance Program, ZOLL
should be notified of any device failures or malfunctions.
This information is required to assure that ZOLL provides
only the highest quality products.
Warranty (U.S. Only)
(a) ZOLL Medical Corporation warrants to the original
equipment purchaser that beginning on the date of
installation, or thirty (30) days after the date of shipment
from ZOLL Medical Corporation's facility, whichever first
occurs, the equipment (other than accessories and
electrodes) will be free from defects in material and
workmanship under normal use and service for the
period of one (1) year. During such period ZOLL Medical
Corporation will, at no charge to the customer, either
repair or replace (at ZOLL Medical Corporation's sole
option) any part of the equipment found by ZOLL Medical
Corporation to be defective in material or workmanship.
If ZOLL Medical Corporation's inspection detects no
defects in material or workmanship, ZOLL Medical
Corporation's regular service charges shall apply. (b)
ZOLL Medical Corporation shall not be responsible for
any equipment defect, the failure of the equipment to
perform any function, or any other nonconformance of
the equipment, caused by or attributable to: (i) any
modification of the equipment by the customer, unless
such modification is made with the prior written approval
of ZOLL Medical Corporation; (ii) the use of the
equipment with any associated or complementary
equipment, (iii) installation or wiring of the equipment
other than in accordance with ZOLL Medical
Corporation's instructions. (c) This warranty does not
cover items subject to normal wear and burnout during
use, including but not limited to lamps, fuses, batteries,
patient cables and accessories. (d) The foregoing
warranty constitutes the exclusive remedy of the
customer and the exclusive liability of ZOLL Medical
Corporation for any breach of any warranty related to the
equipment supplied hereunder. (e) Limitation of Liability:
ZOLL shall not in any event be liable to Purchaser, nor
shall Purchaser recover, for special, incidental or
consequential damages resulting from any breach of
warranty, failure of essential purpose, or under any other
legal theory including but not limited to lost profits, lost
savings, downtime, goodwill, damage to or replacement
of equipment and property, even if ZOLL has been
advised of the possibility of such damages.
THE WARRANTY SET FORTH HEREIN IS EXCLUSIVE
AND ZOLL MEDICAL CORPORATION EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES WHETHER
WRITTEN, ORAL, IMPLIED, OR STATUTORY,
INCLUDING BUT NOT LIMITED TO ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
For additional information, please call ZOLL Medical
Corporation at 1-800-348-9011. International customers
should call the nearest authorized ZOLL Medical
Corporation service center.