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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gas-machine, anesthesia
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUTRON, INC.
  SUBSTANTIALLY EQUIVALENT 2
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 17
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 35
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MATRIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 17
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
Malfunction 8
Device displays error message 5
Valve(s), defective 4
Other (for use when an appropriate device code cannot be identified) 4
Device operates differently than expected 4
Failure to cycle 3
Improper gas output 3
Computer software issue 3
Increase in pressure 2
Mechanical issue 2
Failure to deliver 2
Connection error 2
Use of Device Issue 1
Battery failure 1
Failure, intermittent 1
Monitor failure 1
Design/structure problem 1
Device emits odor 1
Failure to power-up 1
Fail-safe design failure 1
Gas delivery system failure 1
Total Device Problems 51

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 1 0 3 0
Class II 1 5 2 7 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accutron Inc I Oct-09-2012
2 Blease Medical Equipment, Ltd. II Apr-16-2010
3 Datex - Ohmeda, Inc II Oct-06-2008
4 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
5 Draeger Medical Systems, Inc. II Sep-23-2010
6 Draeger Medical, Inc. II Oct-08-2008
7 Draeger Medical, Inc. II Sep-23-2008
8 Draeger Medical, Inc. II Jul-16-2008
9 GE Healthcare II Jul-30-2009
10 GE Healthcare II Jun-23-2009
11 GE Healthcare, LLC II Oct-06-2010
12 Ge Healthcare, Llc I May-11-2010
13 MAQUET Inc. II Sep-07-2007
14 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
15 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
16 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
17 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
18 Penlon, Ltd. II Mar-26-2012
19 Philips Healthcare Inc. II Aug-24-2010
20 Spacelabs Healthcare, Llc II Dec-27-2010
21 Spacelabs Healthcare, Llc II Jul-29-2010

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