Company: Medi-Stat Inc.
Product: Pulse oximeter sensors
Date: 10/17/03
The Device Master Record you submitted is inadequate. A Device Master Record is specific for each device and must include or refer to the location of the following information: a.) device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications; b.) production process specifications including the appropriate equipment specifications, production methods, production procedures and production environment specifications; c.) quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; d.) packaging and labeling specifications, including methods and processes used; and e.) installation, maintenance and servicing procedures and methods. The Device Master Record you submitted is inadequate in that it does not specifically contain all of the required information listed above for each type of oximeter sensor you reprocess. The Device History Record you attached is also inadequate in that it does not demonstrate that each device was reprocessed in accordance with the Device Master Record. For example, as discussed above, the Device Tracking Form does not document the testing results to show that the released devices meet specifications. All acceptance records must be contained in the Device History Record, as well as the dates of reprocessing, quantity reprocessed, quantity released, the primary identification label and labeling used for each production unit, as well as any device identification and control numbers used.
Failure to establish and maintain procedures to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes, is capable of producing valid results, and is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72. For example:
FDA District: Denver District Office
