Cardiac Assist, Inc. - Feb. 7, 2014
Issue Date
Feb 07, 2014
Region
Central
Category
Device
$117.00
Contact Name
Kevin W. Posey
Contact Title
Director of Quality
Address 1
240 Alpha Dr.
City
Pittsburgh
State
PA
Zip/Postal Code
15238-2906
Country
United States
Inspection Range
Jan 24, 2014 - Feb 07, 2014
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Katelyn A. Staub-Zamperini