Ventec Life Systems, Inc. - July 27, 2022
Issue Date
Jul 27, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Joseph Cipollone
Contact Title
EVP Respiratory Operations
Address 1
22002 26th Ave. SE
City
Bothell
State
WA
Zip/Postal Code
98021-4903
Inspection Range
Jul 14, 2022 - Jul 27, 2022
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): Stephen R. Souza