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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 4
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
Device operates differently than expected 898
No code available 654
Device displays error message 312
Device alarm system issue 289
Leak 234
Pressure issue 210
Mechanical issue 206
Device inoperable 135
Suction issue 112
Tidal volume fluctuations 108
Break 82
Excess flow or overinfusion 55
No display or display failure 48
Infusion or flow issue 33
Sticking 31
Increase in pressure 21
Loss of power 21
Computer software issue 19
Battery issue 19
Air leak 14
Device stops intermittently 13
Failure to deliver 12
Defective Alarm 11
Inappropriate or unexpected reset 11
Data Issue 11
Power source issue 9
Electrical issue 9
Blockage within device or device component 8
Malfunction 8
Failure to power-up 8
Reset issue 8
Dislodged or dislocated 8
High Readings 8
Failure to calibrate 7
Computer operating system issue 6
Improper flow or infusion 6
Operating system becomes non-functional 6
Not audible alarm 6
Improper gas output 5
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
Use of Device Issue 5
No flow 5
Improper device output 4
Connection issue 4
Calibration issue 4
Device damaged prior to use 4
Valve(s), defective 4
Alarm not visible 4
Incorrect display 4
Crack 4
Failure to cycle 3
Deflation issue 3
Disconnection 3
Failure to run on AC/DC 3
Component falling 3
No device output 3
Inflation issue 3
Loose or intermittent connection 3
Tipover 3
Communication or transmission issue 3
Delivery system failure 3
Failure of device to self-test 3
No Known Device Problem 3
Noise, Audible 3
No Information 2
Output issue 2
Moisture or humidity problem 2
Gas leak 2
Incorrect measurement 2
Misconnection 2
Improper or incorrect procedure or method 2
Insufficient flow or underinfusion 2
Component missing 2
Inaccurate delivery 2
Detachment of device component 2
Connection error 2
Premature discharge of battery 2
Low audible alarm 2
Decrease in suction 2
Application interface becomes non-functional or program exits abnormally 2
False device output 2
Fire 2
Fluid leak 1
Gas delivery system failure 1
Fail-safe design failure 1
Failure, intermittent 1
Erratic display 1
Design/structure problem 1
Failure to convert to back-up 1
Battery failure 1
Burn of device or device component 1
Obstruction within device 1
Unknown (for use when the device problem is not known) 1
Unstable 1
Monitor failure 1
Nonstandard device or device component 1
Device emits odor 1
Image display error 1
Decrease in pressure 1
Total Device Problems 3808

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 2
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. II May-16-2017
6 Del Mar Reynolds Medical, Ltd. I Nov-20-2013
7 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
8 Draeger Medical Systems, Inc. II Sep-23-2010
9 Draeger Medical, Inc. I Dec-12-2015
10 Draeger Medical, Inc. II Jul-27-2015
11 Draeger Medical, Inc. I Oct-10-2013
12 Draeger Medical, Inc. II Oct-08-2008
13 Draeger Medical, Inc. II Sep-23-2008
14 Draeger Medical, Inc. II Jul-16-2008
15 GE Healthcare II Apr-02-2015
16 GE Healthcare II Jul-30-2009
17 GE Healthcare II Jun-23-2009
18 GE Healthcare, LLC II May-24-2017
19 GE Healthcare, LLC II Dec-14-2016
20 GE Healthcare, LLC I Oct-15-2013
21 GE Healthcare, LLC I Oct-15-2013
22 GE Healthcare, LLC II Sep-06-2013
23 GE Healthcare, LLC II Jun-03-2013
24 GE Healthcare, LLC II Oct-06-2010
25 GE Medical Systems, LLC II Apr-22-2016
26 GE Medical Systems, LLC II Apr-13-2016
27 GE Medical Systems, LLC II Jan-21-2016
28 Ge Healthcare, Llc I May-11-2010
29 MAQUET Inc. II Sep-07-2007
30 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
31 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
32 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
33 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
34 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
35 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
36 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
37 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
38 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
39 Penlon, Ltd. II Mar-26-2012
40 Philips Healthcare Inc. II Aug-24-2010
41 Spacelabs Healthcare, Llc II Dec-27-2010
42 Spacelabs Healthcare, Llc II Jul-29-2010

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