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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
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGILENT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ANESTHESIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEAR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BLEASE MEDICAL EQUIPMENT LTD.
  SUBSTANTIALLY EQUIVALENT 4
CAREFUSION
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
CHARLES A. SMITH
  SUBSTANTIALLY EQUIVALENT 2
CHEMETRON HEALTH SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CODONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSTEX INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DATEX DIVISION INSTRUMENTARIUM CORP.
  SUBSTANTIALLY EQUIVALENT 4
DATEX-ENGSTROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 4
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 23
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DOCUSYS
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 35
DRAEGER MEDICAL AG & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 33
DRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRASER HARLAKE, INC.
  SUBSTANTIALLY EQUIVALENT 1
G. DUNDAS CO.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 5
HEWLETT-PACKARD GMBH
  SUBSTANTIALLY EQUIVALENT 1
HEYER AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOSPITRONIC
  SUBSTANTIALLY EQUIVALENT 1
INTERA INTL.
  SUBSTANTIALLY EQUIVALENT 1
JAMES MARK CRAWFORD
  SUBSTANTIALLY EQUIVALENT 1
MALLARD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 ...
MATRIX MEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MATRIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL AND INDUSTRIAL EQUIPMENT
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INDUSTRIAL EQUIPMENT
  SUBSTANTIALLY EQUIVALENT 1
MEDIMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISHIELD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY DS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MODULAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NARCO SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OHIO MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP
  SUBSTANTIALLY EQUIVALENT 2
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 17
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATIENT DATA SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PENLON LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENLON, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 3
PREMIER ANESTHESIA SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SAFER SLEEP LLC
  SUBSTANTIALLY EQUIVALENT 1
SHASTA LOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS ELEMA AB
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS LIFE SUPPORT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHNICAL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THORNHILL RESEARCH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
TREK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS RESPIRATORY C
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
W.E. LEDER ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device operates differently than expected 1395
No code available 941
Device alarm system issue 517
Device displays error message 417
Leak 340
Pressure issue 238
Mechanical issue 221
Device inoperable 209
Suction issue 173
Tidal volume fluctuations 135
Break 108
Excess flow or overinfusion 95
No display or display failure 63
Sticking 54
High Readings 38
Infusion or flow issue 36
Battery issue 26
Increase in pressure 25
Loss of power 22
Computer software issue 16
Defective Alarm 15
Device stops intermittently 15
Air leak 14
Failure to deliver 12
Inappropriate or unexpected reset 11
Power source issue 11
Data Issue 11
Not audible alarm 10
Electrical issue 9
Failure to power-up 9
Blockage within device or device component 9
Reset issue 8
Failure of device to self-test 8
Dislodged or dislocated 8
Failure to calibrate 7
Improper gas output 7
Crack 7
Incorrect display 7
Improper flow or infusion 6
Output issue 6
Device damaged prior to use 6
Malfunction 6
Detachment of device component 6
Computer operating system issue 6
Operating system becomes non-functional 6
Gas leak 5
Improper device output 5
Defective component 5
No flow 5
Connection issue 5
Inaccurate delivery 5
Noise, Audible 5
Calibration issue 5
Other (for use when an appropriate device code cannot be identified) 4
Disconnection 4
Alarm not visible 4
Use of Device Issue 4
Inflation issue 4
Communication or transmission issue 4
Deflation issue 3
Tipover 3
Premature discharge of battery 3
No Known Device Problem 3
Decrease in suction 3
Loose or intermittent connection 3
Component falling 3
No device output 3
Delivery system failure 3
Failure to run on AC/DC 3
Incorrect or inadequate test results 3
No Information 2
Low audible alarm 2
Connection error 2
Insufficient flow or underinfusion 2
Moisture or humidity problem 2
False device output 2
Obstruction within device 2
Incorrect measurement 2
Component missing 2
Fire 2
Issue with displayed error message 2
Improper or incorrect procedure or method 2
Application interface becomes non-functional or program exits abnormally 2
Misconnection 2
Unstable 1
Failure to fire 1
Device sensing issue 1
Flare or flash 1
False reading from device non-compliance 1
Human-Device Interface Issue 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Smoking 1
Unknown (for use when the device problem is not known) 1
Inadequate lighting 1
Failure, intermittent 1
Occlusion within device 1
Electrical power problem 1
Device emits odor 1
Material separation 1
Total Device Problems 5430

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Class I 0 0 0 1 0 3 4 1 2 1 1 0
Class II 1 5 2 7 0 2 2 0 3 6 2 3
Class III 0 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 Mar-26-2018
19 GE Healthcare, LLC II May-24-2017
20 GE Healthcare, LLC II Dec-14-2016
21 GE Healthcare, LLC I Oct-15-2013
22 GE Healthcare, LLC I Oct-15-2013
23 GE Healthcare, LLC II Sep-06-2013
24 GE Healthcare, LLC II Jun-03-2013
25 GE Healthcare, LLC II Oct-06-2010
26 GE Medical Systems China Co., Ltd. II Feb-09-2018
27 GE Medical Systems, LLC II Apr-22-2016
28 GE Medical Systems, LLC II Apr-13-2016
29 GE Medical Systems, LLC II Jan-21-2016
30 Ge Healthcare, Llc I May-11-2010
31 MAQUET Inc. II Sep-07-2007
32 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
33 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
34 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
35 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
36 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
37 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
38 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
39 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
40 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
41 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
42 Penlon, Ltd. II Mar-26-2012
43 Philips Healthcare Inc. II Aug-24-2010
44 Spacelabs Healthcare, Llc II Dec-27-2010
45 Spacelabs Healthcare, Llc II Jul-29-2010
46 Spacelabs Healthcare, Ltd. I Nov-21-2017

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