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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
  1.  K102182  MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 ...
  2.  K112114  MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW- ...
  3.  K133958  FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
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 305
Device displays error message 162
Pressure issue 100
Device inoperable 91
Device operates differently than expected 81
Mechanical issue 56
Tidal volume fluctuations 52
Leak 42
No display or display failure 30
Break 25
Device alarm system issue 24
Suction issue 23
Loss of power 17
Computer software issue 16
Infusion or flow issue 13
Failure to deliver 12
Increase in pressure 11
Battery issue 11
Air leak 11
Excess flow or overinfusion 10
Device stops intermittently 9
Data Issue 8
Electrical issue 8
Inappropriate or unexpected reset 8
Failure to power-up 8
Malfunction 8
Defective Alarm 8
Power source issue 7
Blockage within device or device component 6
Other (for use when an appropriate device code cannot be identified) 5
No flow 5
Dislodged or dislocated 4
Valve(s), defective 4
Defective component 4
Operating system becomes non-functional 4
Failure to cycle 4
Sticking 4
Reset issue 4
Computer operating system issue 4
No Information 3
Failure to run on AC/DC 3
Improper device output 3
Connection issue 3
Improper gas output 3
Tipover 2
Use of Device Issue 2
Ventilation issue in device environment 2
Improper or incorrect procedure or method 2
Application interface becomes non-functional or program exits abnormally 2
Misconnection 2
Fire 2
Inflation issue 2
Low audible alarm 2
Connection error 2
Incorrect display 2
Noise, Audible 2
No device output 2
Moisture or humidity problem 2
Disconnection 2
Loose or intermittent connection 2
False device output 2
Mechanical jam 1
Protective measure issue 1
Patient Data Issue 1
Material separation 1
Application program issue 1
Device emits odor 1
Design/structure problem 1
Electrical shorting 1
Fail-safe design failure 1
Gas delivery system failure 1
Image display error 1
Monitor failure 1
Decrease in suction 1
Failure to convert to back-up 1
Component falling 1
Inaccurate delivery 1
Incorrect or inadequate test results 1
Defective item 1
Delivery system failure 1
Detachment of device or device component 1
Improper flow or infusion 1
Fluid leak 1
Nonstandard device or device component 1
Communication or transmission issue 1
Unstable 1
Device sensing issue 1
No Known Device Problem 1
Battery failure 1
Failure, intermittent 1
Not Applicable 1
Not audible alarm 1
Deflation issue 1
Obstruction within device 1
Failure to calibrate 1
Total Device Problems 1287

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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