The subject device is not available for evaluation, as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.The device history record (dhr) was not reviewed as the lot number was not provided.Also, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Based on the information received, use error most likely contributed to the event.There was no indication or allegation of a device malfunction contributing to the event.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.
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