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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
MATRIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K010613  MAGELLAN-2200, MODEL 1
  2.  K060193  MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
  3.  K072420  MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
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
Device operates differently than expected 633
No code available 516
Device displays error message 279
Device alarm system issue 223
Mechanical issue 196
Pressure issue 186
Leak 165
Device inoperable 134
Tidal volume fluctuations 101
Suction issue 82
Break 69
No display or display failure 44
Infusion or flow issue 29
Excess flow or overinfusion 23
Sticking 23
Increase in pressure 21
Battery issue 19
Loss of power 17
Computer software issue 17
Air leak 13
Device stops intermittently 12
Failure to deliver 12
Inappropriate or unexpected reset 11
Data Issue 11
Defective Alarm 10
Electrical issue 9
Power source issue 9
Reset issue 8
Blockage within device or device component 8
Malfunction 8
Failure to power-up 8
Operating system becomes non-functional 6
Dislodged or dislocated 6
Computer operating system issue 6
No flow 5
Defective component 5
Other (for use when an appropriate device code cannot be identified) 5
Improper gas output 5
Incorrect display 4
Crack 4
Alarm not visible 4
Valve(s), defective 4
Device damaged prior to use 4
Improper device output 4
Connection issue 4
Calibration issue 4
Communication or transmission issue 3
Failure to calibrate 3
Delivery system failure 3
Improper flow or infusion 3
Tipover 3
Failure of device to self-test 3
Noise, Audible 3
Use of Device Issue 3
No device output 3
Loose or intermittent connection 3
Component falling 3
Inflation issue 3
Not audible alarm 3
Failure to run on AC/DC 3
Failure to cycle 3
Decrease in suction 2
Deflation issue 2
Disconnection 2
False device output 2
Fire 2
Low audible alarm 2
Premature discharge of battery 2
Application interface becomes non-functional or program exits abnormally 2
Connection error 2
Detachment of device component 2
Misconnection 2
Improper or incorrect procedure or method 2
No Information 2
Gas leak 2
Moisture or humidity problem 2
Output issue 1
No Known Device Problem 1
No Pressure 1
Low battery impedance 1
Mechanical jam 1
Human-Device Interface Issue 1
Failure to shut off 1
Detachment of device or device component 1
Electrical power problem 1
Electrical shorting 1
Device sensing issue 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Failure to fire 1
Application program issue 1
Patient Data Issue 1
Not Applicable 1
Protective measure issue 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Insufficient flow or underinfusion 1
Obstruction within device 1
Inaccurate delivery 1
Total Device Problems 3065

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 3 4 1 2 1 0
Class II 1 5 2 7 0 2 2 0 3 6 0
Class III 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. I Nov-20-2013
6 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
7 Draeger Medical Systems, Inc. II Sep-23-2010
8 Draeger Medical, Inc. I Dec-12-2015
9 Draeger Medical, Inc. II Jul-27-2015
10 Draeger Medical, Inc. I Oct-10-2013
11 Draeger Medical, Inc. II Oct-08-2008
12 Draeger Medical, Inc. II Sep-23-2008
13 Draeger Medical, Inc. II Jul-16-2008
14 GE Healthcare II Apr-02-2015
15 GE Healthcare II Jul-30-2009
16 GE Healthcare II Jun-23-2009
17 GE Healthcare, LLC II Dec-14-2016
18 GE Healthcare, LLC I Oct-15-2013
19 GE Healthcare, LLC I Oct-15-2013
20 GE Healthcare, LLC II Sep-06-2013
21 GE Healthcare, LLC II Jun-03-2013
22 GE Healthcare, LLC II Oct-06-2010
23 GE Medical Systems, LLC II Apr-22-2016
24 GE Medical Systems, LLC II Apr-13-2016
25 GE Medical Systems, LLC II Jan-21-2016
26 Ge Healthcare, Llc I May-11-2010
27 MAQUET Inc. II Sep-07-2007
28 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
29 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
30 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
31 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
32 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
33 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
34 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
35 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
36 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
37 Penlon, Ltd. II Mar-26-2012
38 Philips Healthcare Inc. II Aug-24-2010
39 Spacelabs Healthcare, Llc II Dec-27-2010
40 Spacelabs Healthcare, Llc II Jul-29-2010

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