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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
  1.  K080175  NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-0 ...
  2.  K123211  A5 ANESTHESIA DELIVERY SYSTEM
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 21
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 35
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1

Device Problems
No code available 354
Device displays error message 187
Pressure issue 108
Device operates differently than expected 96
Device inoperable 93
Mechanical issue 73
Tidal volume fluctuations 62
Leak 47
Device alarm system issue 35
No display or display failure 32
Break 28
Suction issue 26
Loss of power 18
Infusion or flow issue 17
Computer software issue 16
Increase in pressure 12
Failure to deliver 12
Battery issue 11
Air leak 11
Excess flow or overinfusion 11
Data Issue 11
Device stops intermittently 10
Inappropriate or unexpected reset 9
Failure to power-up 8
Malfunction 8
Electrical issue 8
Defective Alarm 8
Blockage within device or device component 7
Power source issue 7
Reset issue 6
No flow 5
Sticking 5
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
Valve(s), defective 4
Computer operating system issue 4
Connection issue 4
Failure to cycle 4
Operating system becomes non-functional 4
Dislodged or dislocated 4
Improper device output 3
No Information 3
Failure to run on AC/DC 3
Improper gas output 3
Use of Device Issue 3
Improper or incorrect procedure or method 2
No device output 2
Loose or intermittent connection 2
Inflation issue 2
Misconnection 2
Incorrect display 2
False device output 2
Fire 2
Low audible alarm 2
Not audible alarm 2
Decrease in suction 2
Disconnection 2
Connection error 2
Application interface becomes non-functional or program exits abnormally 2
Ventilation issue in device environment 2
Noise, Audible 2
Moisture or humidity problem 2
Tipover 2
Mechanical jam 1
No Known Device Problem 1
No Pressure 1
Improper flow or infusion 1
Device sensing issue 1
Electrical shorting 1
Failure of device to self-test 1
Human-Device Interface Issue 1
Not Applicable 1
Protective measure issue 1
Patient Data Issue 1
Deflation issue 1
Design/structure problem 1
Failure to convert to back-up 1
Battery failure 1
Component falling 1
Fluid leak 1
Gas delivery system failure 1
Fail-safe design failure 1
Failure, intermittent 1
Monitor failure 1
Nonstandard device or device component 1
Device emits odor 1
Image display error 1
Material separation 1
Unstable 1
Inaccurate delivery 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Defective item 1
Delivery system failure 1
Detachment of device or device component 1
Communication or transmission issue 1
Application program issue 1
Total Device Problems 1461

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 3 4 1 2 1
Class II 1 5 2 7 0 2 2 0 3 3
Class III 0 0 0 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. I Nov-20-2013
5 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
6 Draeger Medical Systems, Inc. II Sep-23-2010
7 Draeger Medical, Inc. I Dec-12-2015
8 Draeger Medical, Inc. II Jul-27-2015
9 Draeger Medical, Inc. I Oct-10-2013
10 Draeger Medical, Inc. II Oct-08-2008
11 Draeger Medical, Inc. II Sep-23-2008
12 Draeger Medical, Inc. II Jul-16-2008
13 GE Healthcare II Apr-02-2015
14 GE Healthcare II Jul-30-2009
15 GE Healthcare II Jun-23-2009
16 GE Healthcare, LLC I Oct-15-2013
17 GE Healthcare, LLC I Oct-15-2013
18 GE Healthcare, LLC II Sep-06-2013
19 GE Healthcare, LLC II Jun-03-2013
20 GE Healthcare, LLC II Oct-06-2010
21 GE Medical Systems, LLC II Apr-22-2016
22 GE Medical Systems, LLC II Apr-13-2016
23 GE Medical Systems, LLC II Jan-21-2016
24 Ge Healthcare, Llc I May-11-2010
25 MAQUET Inc. II Sep-07-2007
26 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
27 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
28 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
29 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
30 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
31 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
32 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
33 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
34 Penlon, Ltd. II Mar-26-2012
35 Philips Healthcare Inc. II Aug-24-2010
36 Spacelabs Healthcare, Llc II Dec-27-2010
37 Spacelabs Healthcare, Llc II Jul-29-2010

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