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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
  1.  K052335  ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
  2.  K992421  GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
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
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 1314
No code available 860
Device alarm system issue 454
Device displays error message 383
Leak 320
Pressure issue 232
Mechanical issue 215
Device inoperable 207
Suction issue 155
Tidal volume fluctuations 128
Break 96
Excess flow or overinfusion 84
No display or display failure 59
Sticking 47
Infusion or flow issue 36
High Readings 32
Increase in pressure 23
Battery issue 22
Loss of power 21
Computer software issue 16
Defective Alarm 15
Air leak 14
Device stops intermittently 14
Failure to deliver 12
Inappropriate or unexpected reset 11
Data Issue 11
Power source issue 10
Not audible alarm 10
Blockage within device or device component 9
Electrical issue 9
Failure to power-up 9
Reset issue 8
Dislodged or dislocated 8
Failure to calibrate 7
Improper gas output 7
Incorrect display 6
Malfunction 6
Device damaged prior to use 6
Computer operating system issue 6
Operating system becomes non-functional 6
Improper flow or infusion 6
Improper device output 5
No flow 5
Calibration issue 5
Gas leak 5
Defective component 5
Crack 5
Detachment of device component 4
Alarm not visible 4
Disconnection 4
Other (for use when an appropriate device code cannot be identified) 4
Use of Device Issue 4
Inaccurate delivery 4
Failure of device to self-test 4
Communication or transmission issue 4
Connection issue 4
Output issue 4
Noise, Audible 4
No Known Device Problem 3
Tipover 3
Delivery system failure 3
Incorrect or inadequate test results 3
Loose or intermittent connection 3
No device output 3
Decrease in suction 3
Deflation issue 3
Inflation issue 3
Failure to run on AC/DC 3
Component falling 3
Application interface becomes non-functional or program exits abnormally 2
Connection error 2
Low audible alarm 2
Premature discharge of battery 2
False device output 2
Fire 2
Incorrect measurement 2
Misconnection 2
Obstruction within device 2
Improper or incorrect procedure or method 2
Insufficient flow or underinfusion 2
Component missing 2
Moisture or humidity problem 2
No Information 2
Patient Data Issue 1
Low battery impedance 1
Mechanical jam 1
Inadequate lighting 1
Inadequate user interface 1
No Pressure 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Protective measure issue 1
Detachment of device or device component 1
Failure to fire 1
Application program issue 1
Failure to shut off 1
Flare or flash 1
Human-Device Interface Issue 1
Electrical power problem 1
Electrical shorting 1
Total Device Problems 5046

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

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