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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
  1.  K000706  DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
  2.  K032803  DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
  3.  K040743  MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA ...
  4.  K042154  GE DATEX-OHMEDA AISYS CARESTATION
  5.  K050055  GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
  6.  K050626  GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
  7.  K050676  GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
  8.  K061609  GE DATEX-OHMEDA AISYS
  9.  K071142  GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
  10.  K073707  GE DATEX-OHMEDA AISYS
  11.  K081844  GE DATEX-OHMEDA AVANCE
  12.  K090233  GE DATEX-OHMEDA AISYS
  13.  K110213  GE DATEX-OHMEDA AISYS
  14.  K112722  GE DATEX-OHMEDA AVANCE
  15.  K122445  AESPIRE 7900, AESPIRE VIEW
  16.  K123125  GE DATEX-OHMEDA AVANCE CS2
  17.  K131945  GE DATEX-OHMEDA AVANCE CS2
  18.  K132530  GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
  19.  K143530  Aespire View
  20.  K151570  Carestation 620/650/650C
  21.  K993410  DATES-OHMEDA AESTIVA SMARTVENT MRI
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 35
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 4
MATRIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OCEANIC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 772
No code available 555
Device displays error message 292
Device alarm system issue 253
Mechanical issue 204
Leak 202
Pressure issue 195
Device inoperable 134
Tidal volume fluctuations 106
Suction issue 94
Break 77
No display or display failure 47
Infusion or flow issue 33
Sticking 25
Excess flow or overinfusion 25
Increase in pressure 21
Loss of power 19
Battery issue 19
Computer software issue 18
Air leak 14
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
Dislodged or dislocated 7
Operating system becomes non-functional 6
Computer operating system issue 6
Failure to calibrate 5
No flow 5
Improper gas output 5
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
Not audible alarm 5
Alarm not visible 4
Incorrect display 4
Crack 4
Valve(s), defective 4
Use of Device Issue 4
Improper device output 4
Device damaged prior to use 4
Connection issue 4
Calibration issue 4
Communication or transmission issue 3
Delivery system failure 3
Tipover 3
Improper flow or infusion 3
Failure of device to self-test 3
Noise, Audible 3
No device output 3
Inflation issue 3
Loose or intermittent connection 3
Failure to cycle 3
Deflation issue 3
Disconnection 3
Failure to run on AC/DC 3
Component falling 3
Detachment of device component 2
Connection error 2
Premature discharge of battery 2
Low audible alarm 2
Decrease in suction 2
Application interface becomes non-functional or program exits abnormally 2
False device output 2
Fire 2
Incorrect measurement 2
Misconnection 2
Improper or incorrect procedure or method 2
Insufficient flow or underinfusion 2
Inaccurate delivery 2
No Information 2
Gas leak 2
Output issue 2
Moisture or humidity problem 2
Low battery impedance 1
Mechanical jam 1
No Known Device Problem 1
No Pressure 1
Human-Device Interface Issue 1
Failure to shut off 1
Electrical power problem 1
Electrical shorting 1
Failure to fire 1
Application program issue 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Detachment of device or device component 1
Device sensing issue 1
Patient Data Issue 1
Not Applicable 1
Protective measure issue 1
Obstruction within device 1
Component missing 1
Total Device Problems 3392

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

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