Lifewatch Services, Inc. - 9/14/2012
Issue Date
Sep 14, 2012
Region
Central
Category
Device
$117.00
Address 1
10255 W Higgins Rd
Address 2
Suite 700 O'Hare International Center
City
Rosemont
State
IL
Zip/Postal Code
60018
Country
United States
Inspection Range
Aug 16, 2012 - Sep 14, 2012
Pages
5
First Observation
An MDR Report was not submitted within 30 days of receiving 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): James W. Plucinski