Fda Tracking Requirements; Notification Of Adverse Events - ZOLL 330 Operator's Manual

Possession or purchase of this device does not convey any expressed or implied license to
•
use the device with unauthorized sensors or cables, which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors, cables, or patient circuits.
Do not leave the device in the bed or cot with the patient to avoid possible heat build-up.
•

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of aspirators. Under this law, owners
of this aspirator 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:
1. Originator's organization – Company name, address, contact name, and contact phone
number.
Model number, and serial number of the aspirator.
2.
Disposition of the aspirator (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.
906-0330-01-01 Rev. D ZOLL 330 Multifunction Aspirator Operator's Guide
General Information
1-9