Compact / Series 7600 Installation Procedure
3
Accident Reporting
The Medical Device Reporting Regulation, 21 CFR Part 803, requires that the
manufacturers of medical devices submit a report to the appropriate federal
agency containing specific information in the event of an accident resulting in
death or serious injury during the use or service of its medical devices. (In the
following paragraphs, labeling definitions include all instructional and
procedural text contained in the Operator's Guide and Periodic Maintenance
Procedures.)
A report is not necessary if:
•
The potential for death or the type of serious injury that may result
appears in the labeling for the system.
•
The malfunction and the routine service, repair, or maintenance in-
structions to correct the problems appear in the labeling for the system.
•
The malfunction has occurred at or below its expected rate of frequency
and severity.
•
The malfunction does not lead the manufacturer to undertake a remedial
action involving any other systems.
For OEC Medical Systems, Inc. to meet these reporting requirements, all users
of these systems, operators, and service technicians, must provide the QA
Manager of OEC Medical Systems, Inc. with the following information regarding
all reportable events as soon as possible:
1.
Identify the model and the serial number.
2.
Describe the event. Include whether any serious injury or death occurred,
the number of personnel injured, and any publication title and dates of any
articles in the scientific or medical literature describing the reported event.
3.
Identify the person who is submitting the information, include their address,
to OEC Medical Systems, Inc.
4.
Indicate whether additional information will be submitted, and if so, when.
5.
Indicate whether the event being reported has occurred with greater
frequency or severity than is indicated in the labeling for the system, or is
unusual for this type of system.
Unauthorized Modifications
Unauthorized changes or modifications to any part of the system could have
hazardous consequences. Changes or modifications are forbidden unless
specifically authorized by OEC Medical Systems, Inc.
Used and Refurbished C-Arms are Available from www.SharpMedical.com - Call us at 800-969-9800
An Independent C-Arm Service Provider. This PDF provided for research / historical purposes only.
