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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
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 3
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 14
DOCUSYS
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL AG & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
DRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 5
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 4
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 4
  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
  4.  K160665  FLOW-i Anesthesia System C20, FLOW-i Anesthesia Sy ...
MCKESSON TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY DS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
THORNHILL RESEARCH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1401
No code available 1081
Device alarm system issue 582
Device displays error message 457
Leak 373
Pressure issue 243
Mechanical issue 225
Device inoperable 209
Suction issue 185
Tidal volume fluctuations 142
Break 121
Excess flow or overinfusion 105
No display or display failure 67
Sticking 62
High Readings 54
Infusion or flow issue 36
Battery issue 27
Increase in pressure 25
Loss of power 22
Defective Alarm 16
Computer software issue 16
Device stops intermittently 15
Air leak 14
Failure to deliver 12
Inappropriate or unexpected reset 11
Data Issue 11
Power source issue 11
Not audible alarm 10
Failure of device to self-test 10
Blockage within device or device component 9
Failure to power-up 9
Electrical issue 9
Dislodged or dislocated 8
Reset issue 8
Crack 8
Incorrect display 7
Improper flow or infusion 7
No flow 7
Failure to calibrate 7
Improper gas output 7
Operating system becomes non-functional 6
Gas leak 6
Output issue 6
Malfunction 6
Device damaged prior to use 6
Detachment of device component 6
Computer operating system issue 6
Noise, Audible 5
Inaccurate delivery 5
Calibration issue 5
Inflation issue 5
Defective component 5
Improper device output 5
Connection issue 5
Use of Device Issue 4
Tipover 4
Communication or transmission issue 4
Other (for use when an appropriate device code cannot be identified) 4
Disconnection 4
Alarm not visible 4
Loose or intermittent connection 3
Insufficient flow or underinfusion 3
Component falling 3
Decrease in suction 3
Failure to run on AC/DC 3
No device output 3
Incorrect or inadequate test results 3
Delivery system failure 3
Deflation issue 3
No Known Device Problem 3
Premature discharge of battery 3
Component missing 2
Incorrect measurement 2
Obstruction within device 2
Fire 2
Misconnection 2
Application interface becomes non-functional or program exits abnormally 2
Issue with displayed error message 2
Improper or incorrect procedure or method 2
Connection error 2
Low audible alarm 2
No Information 2
Detachment of device or device component 2
Moisture or humidity problem 2
False device output 2
Mechanical jam 2
Application program issue 1
Protective measure issue 1
Material separation 1
Device emits odor 1
Patient Data Issue 1
Electrical shorting 1
Decrease in pressure 1
Image display error 1
Loss of threshold 1
Arcing 1
Gas delivery system failure 1
No Pressure 1
Failure to convert to back-up 1
Burn of device or device component 1
Total Device Problems 5807

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. II Jun-19-2018
10 Draeger Medical, Inc. I May-08-2018
11 Draeger Medical, Inc. I Dec-12-2015
12 Draeger Medical, Inc. II Jul-27-2015
13 Draeger Medical, Inc. I Oct-10-2013
14 Draeger Medical, Inc. II Oct-08-2008
15 Draeger Medical, Inc. II Sep-23-2008
16 Draeger Medical, Inc. II Jul-16-2008
17 GE Healthcare II Apr-02-2015
18 GE Healthcare II Jul-30-2009
19 GE Healthcare II Jun-23-2009
20 GE Healthcare, LLC II Mar-26-2018
21 GE Healthcare, LLC II May-24-2017
22 GE Healthcare, LLC II Dec-14-2016
23 GE Healthcare, LLC I Oct-15-2013
24 GE Healthcare, LLC I Oct-15-2013
25 GE Healthcare, LLC II Sep-06-2013
26 GE Healthcare, LLC II Jun-03-2013
27 GE Healthcare, LLC II Oct-06-2010
28 GE Medical Systems China Co., Ltd. II Feb-09-2018
29 GE Medical Systems, LLC II Apr-22-2016
30 GE Medical Systems, LLC II Apr-13-2016
31 GE Medical Systems, LLC II Jan-21-2016
32 Ge Healthcare, Llc I May-11-2010
33 MAQUET Inc. II Sep-07-2007
34 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
35 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
36 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
37 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
38 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
39 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
40 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
41 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
42 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
43 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
44 Penlon, Ltd. II Mar-26-2012
45 Philips Healthcare Inc. II Aug-24-2010
46 Spacelabs Healthcare, Llc II Dec-27-2010
47 Spacelabs Healthcare, Llc II Jul-29-2010
48 Spacelabs Healthcare, Ltd. I Nov-21-2017

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