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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 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
  1.  K102471  AS3700 ANESTHSIA DELIVERY SYSTEM
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 414
Device displays error message 237
Device operates differently than expected 215
Pressure issue 138
Mechanical issue 127
Device inoperable 112
Device alarm system issue 86
Leak 77
Tidal volume fluctuations 77
Break 41
No display or display failure 40
Suction issue 34
Infusion or flow issue 24
Loss of power 18
Computer software issue 17
Excess flow or overinfusion 15
Increase in pressure 15
Battery issue 14
Device stops intermittently 12
Failure to deliver 12
Sticking 11
Air leak 11
Inappropriate or unexpected reset 11
Data Issue 11
Electrical issue 9
Defective Alarm 8
Blockage within device or device component 8
Failure to power-up 8
Malfunction 8
Reset issue 7
Power source issue 7
Operating system becomes non-functional 6
Computer operating system issue 6
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
No flow 5
Improper device output 4
Dislodged or dislocated 4
Valve(s), defective 4
Connection issue 4
Failure to cycle 4
Improper gas output 4
Inflation issue 3
Loose or intermittent connection 3
Incorrect display 3
Component falling 3
Failure to run on AC/DC 3
Use of Device Issue 3
Failure of device to self-test 3
No Information 3
Ventilation issue in device environment 2
Moisture or humidity problem 2
Noise, Audible 2
Tipover 2
Improper or incorrect procedure or method 2
No device output 2
Misconnection 2
Low audible alarm 2
Not audible alarm 2
Connection error 2
Decrease in suction 2
Deflation issue 2
Application interface becomes non-functional or program exits abnormally 2
Disconnection 2
False device output 2
Fire 2
Fluid leak 1
Gas delivery system failure 1
Image display error 1
Fail-safe design failure 1
Failure, intermittent 1
Design/structure problem 1
Crack 1
Alarm not visible 1
Failure to convert to back-up 1
Battery failure 1
Detachment of device component 1
Monitor failure 1
Nonstandard device or device component 1
Device emits odor 1
Material separation 1
Unstable 1
Delivery system failure 1
Detachment of device or device component 1
Inaccurate delivery 1
Application program issue 1
Unknown (for use when the device problem is not known) 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Improper flow or infusion 1
No Known Device Problem 1
No Pressure 1
Mechanical jam 1
Failure to shut off 1
Human-Device Interface Issue 1
Electrical shorting 1
Calibration issue 1
Total Device Problems 1965

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

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