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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
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
  1.  K102471  AS3700 ANESTHSIA DELIVERY SYSTEM
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 1396
No code available 1024
Device alarm system issue 543
Device displays error message 430
Leak 362
Pressure issue 239
Mechanical issue 224
Device inoperable 209
Suction issue 179
Tidal volume fluctuations 139
Break 118
Excess flow or overinfusion 102
No display or display failure 64
Sticking 54
High Readings 47
Infusion or flow issue 36
Battery issue 26
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
Data Issue 11
Inappropriate or unexpected reset 11
Power source issue 11
Not audible alarm 10
Failure of device to self-test 10
Blockage within device or device component 9
Electrical issue 9
Failure to power-up 9
Dislodged or dislocated 8
Crack 8
Reset issue 8
Incorrect display 7
Improper gas output 7
Failure to calibrate 7
Detachment of device component 6
Computer operating system issue 6
Improper flow or infusion 6
Operating system becomes non-functional 6
Output issue 6
Device damaged prior to use 6
Malfunction 6
Gas leak 6
No flow 5
Improper device output 5
Connection issue 5
Inflation issue 5
Noise, Audible 5
Inaccurate delivery 5
Calibration issue 5
Defective component 5
Alarm not visible 4
Other (for use when an appropriate device code cannot be identified) 4
Disconnection 4
Communication or transmission issue 4
Use of Device Issue 4
Premature discharge of battery 3
Insufficient flow or underinfusion 3
Deflation issue 3
No device output 3
Component falling 3
Loose or intermittent connection 3
No Known Device Problem 3
Incorrect or inadequate test results 3
Tipover 3
Failure to run on AC/DC 3
Decrease in suction 3
Delivery system failure 3
Misconnection 2
Incorrect measurement 2
False device output 2
Component missing 2
No Information 2
Improper or incorrect procedure or method 2
Obstruction within device 2
Issue with displayed error message 2
Connection error 2
Moisture or humidity problem 2
Fire 2
Application interface becomes non-functional or program exits abnormally 2
Low audible alarm 2
Decrease in pressure 1
Material separation 1
Smoking 1
Failure to fire 1
Application program issue 1
Detachment of device or device component 1
Failure to shut off 1
Protective measure issue 1
Failure to convert to back-up 1
Low battery impedance 1
Material integrity issue 1
Mechanical jam 1
Image display error 1
Loss of threshold 1
Naturally worn 1
Therapeutic or diagnostic output failure 1
Total Device Problems 5623

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 1
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 May-08-2018
10 Draeger Medical, Inc. I Dec-12-2015
11 Draeger Medical, Inc. II Jul-27-2015
12 Draeger Medical, Inc. I Oct-10-2013
13 Draeger Medical, Inc. II Oct-08-2008
14 Draeger Medical, Inc. II Sep-23-2008
15 Draeger Medical, Inc. II Jul-16-2008
16 GE Healthcare II Apr-02-2015
17 GE Healthcare II Jul-30-2009
18 GE Healthcare II Jun-23-2009
19 GE Healthcare, LLC II Mar-26-2018
20 GE Healthcare, LLC II May-24-2017
21 GE Healthcare, LLC II Dec-14-2016
22 GE Healthcare, LLC I Oct-15-2013
23 GE Healthcare, LLC I Oct-15-2013
24 GE Healthcare, LLC II Sep-06-2013
25 GE Healthcare, LLC II Jun-03-2013
26 GE Healthcare, LLC II Oct-06-2010
27 GE Medical Systems China Co., Ltd. II Feb-09-2018
28 GE Medical Systems, LLC II Apr-22-2016
29 GE Medical Systems, LLC II Apr-13-2016
30 GE Medical Systems, LLC II Jan-21-2016
31 Ge Healthcare, Llc I May-11-2010
32 MAQUET Inc. II Sep-07-2007
33 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
34 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
35 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
36 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
37 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
38 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
39 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
40 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
41 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
42 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
43 Penlon, Ltd. II Mar-26-2012
44 Philips Healthcare Inc. II Aug-24-2010
45 Spacelabs Healthcare, Llc II Dec-27-2010
46 Spacelabs Healthcare, Llc II Jul-29-2010
47 Spacelabs Healthcare, Ltd. I Nov-21-2017

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