TPLC - Total Product Life Cycle

• Device: system,network and communication,physiological monitors
• Regulation Description: Cardiac monitor (including cardiotachometer and rate alarm).
• Product Code: MSX
• Regulation Number: 870.2300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
Cardiopulmonary Corp.
	SUBSTANTIALLY EQUIVALENT	3
DATA CRITICAL
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	8
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	9
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	10
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MARQUETTE
	SUBSTANTIALLY EQUIVALENT	2
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SPACELABS HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Device alarm system issue	1
Not audible alarm	1
Total Device Problems	2

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	2	2	1	0	1	2
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare	II	Apr-06-2009
2	GE Healthcare	II	Jun-24-2008
3	GE Healthcare	II	Nov-05-2008
4	GE Medical Systems, LLC	II	Sep-04-2009
5	Ge Healthcare, Llc	II	Aug-12-2010
6	Mindray DS USA, Inc. d.b.a. Mindray North America	II	Feb-11-2013
7	Mindray DS USA, Inc. d.b.a. Mindray North America	II	Jan-03-2013
8	Visicu, Inc.	II	Apr-27-2012