Company: Respironics California Inc.
Product: Espirit mechanical ventilator
Date: 1/27/04
The design validation activities conducted for the Esprit ventilator software version 3.2 failed to ensure that the device conforms to the defined user/patient needs and intended uses [21 CFR 820.30]. Specifically:
There was no documented evidence that any integration and throughput testing of the device was performed to eliminate software communication problems prior to the final acceptance of the design of the device.
The Esprit Throughput Testing Package, a written software test procedure for the throughput testing that is used in conducting software integration testing, was found in use even though it had not been released, controlled, or approved in accordance with written document control procedures [21 CFR 820.40(a)].
We have identified the following concerns that we wish to discuss with you at the meeting:
Design procedures and design history for the Esprit ventilator, especially software changes made to the device;
FDA District: Los Angeles District Office
