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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
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
  1.  K844421  FOREGGER DOME VALVES
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
Device operates differently than expected 502
No code available 480
Device displays error message 259
Device alarm system issue 186
Mechanical issue 186
Pressure issue 165
Leak 134
Device inoperable 129
Tidal volume fluctuations 92
Break 60
Suction issue 59
No display or display failure 42
Infusion or flow issue 28
Excess flow or overinfusion 22
Sticking 19
Loss of power 18
Battery issue 18
Increase in pressure 18
Computer software issue 17
Device stops intermittently 13
Failure to deliver 12
Inappropriate or unexpected reset 11
Data Issue 11
Air leak 11
Defective Alarm 9
Electrical issue 9
Power source issue 8
Malfunction 8
Failure to power-up 8
Blockage within device or device component 8
Reset issue 8
Computer operating system issue 6
Operating system becomes non-functional 6
Failure to cycle 5
Defective component 5
No flow 5
Improper gas output 5
Other (for use when an appropriate device code cannot be identified) 5
Calibration issue 4
Incorrect display 4
Device damaged prior to use 4
Alarm not visible 4
Dislodged or dislocated 4
Connection issue 4
Valve(s), defective 4
Improper device output 4
Inflation issue 3
Tipover 3
Use of Device Issue 3
Not audible alarm 3
Failure of device to self-test 3
Loose or intermittent connection 3
Component falling 3
Crack 3
No Information 3
Noise, Audible 3
Failure to run on AC/DC 3
Improper flow or infusion 3
Delivery system failure 3
No device output 2
Connection error 2
Low audible alarm 2
Disconnection 2
Moisture or humidity problem 2
Decrease in suction 2
Detachment of device component 2
False device output 2
Device emits odor 2
Deflation issue 2
Premature discharge of battery 2
Ventilation issue in device environment 2
Fire 2
Communication or transmission issue 2
Improper or incorrect procedure or method 2
Misconnection 2
Application interface becomes non-functional or program exits abnormally 2
Unstable 1
Device sensing issue 1
Human-Device Interface Issue 1
Failure, intermittent 1
Battery failure 1
No Known Device Problem 1
Obstruction within device 1
Failure to calibrate 1
Incorrect measurement 1
Not Applicable 1
Unknown (for use when the device problem is not known) 1
Patient Data Issue 1
Design/structure problem 1
Material separation 1
Protective measure issue 1
Mechanical jam 1
Application program issue 1
Fail-safe design failure 1
Gas delivery system failure 1
No Pressure 1
Electrical shorting 1
Image display error 1
Arcing 1
Monitor failure 1
Total Device Problems 2716

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 3 4 1 2 1 0
Class II 1 5 2 7 0 2 2 0 3 6 0
Class III 0 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 II Dec-14-2016
18 GE Healthcare, LLC I Oct-15-2013
19 GE Healthcare, LLC I Oct-15-2013
20 GE Healthcare, LLC II Sep-06-2013
21 GE Healthcare, LLC II Jun-03-2013
22 GE Healthcare, LLC II Oct-06-2010
23 GE Medical Systems, LLC II Apr-22-2016
24 GE Medical Systems, LLC II Apr-13-2016
25 GE Medical Systems, LLC II Jan-21-2016
26 Ge Healthcare, Llc I May-11-2010
27 MAQUET Inc. II Sep-07-2007
28 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
29 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
30 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
31 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
32 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
33 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
34 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
35 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
36 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
37 Penlon, Ltd. II Mar-26-2012
38 Philips Healthcare Inc. II Aug-24-2010
39 Spacelabs Healthcare, Llc II Dec-27-2010
40 Spacelabs Healthcare, Llc II Jul-29-2010

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