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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
  1.  K001488  NARKOMED MRI , NM-MRI
  2.  K003579  NARKOMED MRI-2, MODEL NM-MRI-2
  3.  K011404  FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
  4.  K022031  NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
  5.  K030624  MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
  6.  K031400  FABIUS TIRO ANESTHESIA SYSTEM
  7.  K033498  NARKOMED 6400, MODEL NM6400
  8.  K041622  MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIU ...
  9.  K042086  FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESI ...
  10.  K042419  FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
  11.  K042607  PRIMUS US
  12.  K072884  FABIUS MRI
  13.  K081447  FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
  14.  K770554  NARKOMED ANESTHESIA MACHINE
  15.  K771989  CONTINUOUS FLOW ANESTHESIA MACHINE
  16.  K822218  NARKOMED 2A ANESTHESIA MACHINE
  17.  K833147  CENTRALERT
  18.  K851621  BOOM ARM
  19.  K853435  NARKOMED 3 ANESTHESIA SYSTEM
  20.  K861170  NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
  21.  K864447  NARKOMED 2B ANESTHESIA SYSTEM
  22.  K864806  ANESTHESIA RECORDER
  23.  K900328  NARKOMED 2B ANESTHESIA SYSTEM
  24.  K900329  NARKOMED 3 ANESTHESIA SYSTEM
  25.  K900937  O.R. DATA MANAGER
  26.  K901713  NARKOMED 4 ANESTHESIA SYSTEM
  27.  K930351  NARKOMED 2C ANESTHESIA SYSTEM
  28.  K945463  PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
  29.  K963994  NARKOMED GS ANESTHESIA SYSTEM
  30.  K971425  NARKOMED M ANESTHESIA SYSTEM (M)
  31.  K972848  NARKOMED MRI ANESTHESIA SYSTEM
  32.  K973949  PERIOPERATIVE DATA MANAGEMENT SYSTEM
  33.  K974193  NARKOMED ULTRASONIC FLOW SENSOR
  34.  K980553  NARKOMED 6000 MODEL NUMBER NM6000
  35.  K983635  JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
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
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 557
No code available 496
Device displays error message 273
Device alarm system issue 208
Mechanical issue 192
Pressure issue 179
Leak 151
Device inoperable 133
Tidal volume fluctuations 99
Suction issue 75
Break 64
No display or display failure 43
Infusion or flow issue 29
Excess flow or overinfusion 22
Sticking 22
Increase in pressure 20
Battery issue 19
Loss of power 18
Computer software issue 17
Air leak 13
Device stops intermittently 13
Failure to deliver 12
Inappropriate or unexpected reset 11
Data Issue 11
Defective Alarm 10
Electrical issue 9
Power source issue 9
Malfunction 8
Reset issue 8
Blockage within device or device component 8
Failure to power-up 8
Dislodged or dislocated 6
Computer operating system issue 6
Operating system becomes non-functional 6
No flow 5
Defective component 5
Other (for use when an appropriate device code cannot be identified) 5
Improper gas output 5
Failure to cycle 5
Incorrect display 4
Crack 4
Alarm not visible 4
Valve(s), defective 4
Improper device output 4
Connection issue 4
Device damaged prior to use 4
Calibration issue 4
Communication or transmission issue 3
Tipover 3
Delivery system failure 3
Improper flow or infusion 3
Failure of device to self-test 3
No Information 3
Noise, Audible 3
Failure to calibrate 3
Use of Device Issue 3
Loose or intermittent connection 3
Component falling 3
Inflation issue 3
Not audible alarm 3
Failure to run on AC/DC 3
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
Disconnection 2
Decrease in suction 2
Deflation issue 2
False device output 2
Fire 2
Misconnection 2
Device emits odor 2
No device output 2
Improper or incorrect procedure or method 2
Ventilation issue in device environment 2
Gas leak 2
Moisture or humidity problem 2
No Known Device Problem 1
No Pressure 1
Protective measure issue 1
Human-Device Interface Issue 1
Failure to shut off 1
Low battery impedance 1
Mechanical jam 1
Detachment of device or device component 1
Electrical power problem 1
Electrical shorting 1
Device sensing issue 1
Obstruction within device 1
Application program issue 1
Not Applicable 1
Patient Data Issue 1
Unknown (for use when the device problem is not known) 1
Unstable 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Inaccurate delivery 1
Material separation 1
Total Device Problems 2910

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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