Company: Cardiomedics Inc.
Date: 4/13/01
Product: Counter pulsation devices
No procedures for the development of software used to control devices.
The software used for the operation of the CardiAssist CounterPulsation system was not properly validated. Problems with this software have been identified and corrective measures have been undertaken to replace this software version.
Electro Static Discharge controls in the electronic assembly have not been implemented as specified by written procedures.
FDA District: Los Angeles District
