Respironics California, Inc. - May 8, 2014
Issue Date
May 08, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Randall L. Whitfield
Contact Title
Vice President and General Manager
Address 1
2271 Cosmos Ct.
City
Carlsbad
State
CA
Zip/Postal Code
92011
Country
United States
Inspection Range
Apr 14, 2014 - May 08, 2014
Pages
8
First Observation
An MDR was not filed 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 to contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Sonya L. Karsik and Shaquenta Y. Perkins