Natus Medical Incorporated - Aug. 13, 2018
Issue Date
Aug 13, 2018
Region
Pacific
Category
Device
$117.00
Contact Name
Melinda R. Elwood
Contact Title
Sr. Director of Quality Assurance & Regulatory Affairs
Address 1
5900 1st Ave S
City
Seattle
State
WA
Zip/Postal Code
98108-3248
Country
United States
Inspection Range
Aug 07, 2018 - Aug 13, 2018
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