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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 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
  1.  K030939  PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYS ...
  2.  K083413  COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMAT ...
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 707
No code available 532
Device displays error message 288
Device alarm system issue 237
Mechanical issue 198
Pressure issue 194
Leak 187
Device inoperable 134
Tidal volume fluctuations 101
Suction issue 88
Break 73
No display or display failure 46
Infusion or flow issue 32
Sticking 24
Excess flow or overinfusion 23
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
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
Improper device output 4
Connection issue 4
Calibration issue 4
Device damaged prior to use 4
Failure to calibrate 4
Tipover 3
Communication or transmission issue 3
Delivery system failure 3
Improper flow or infusion 3
Failure of device to self-test 3
Noise, Audible 3
Use of Device Issue 3
No device output 3
Inflation issue 3
Loose or intermittent connection 3
Disconnection 3
Failure to cycle 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
Deflation issue 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
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
Detachment of device or device component 1
Device sensing issue 1
Failure to fire 1
Application program issue 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Patient Data Issue 1
Not Applicable 1
Protective measure issue 1
Unstable 1
Component missing 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 3238

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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