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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
No code available 305
Device displays error message 163
Pressure issue 100
Device inoperable 91
Device operates differently than expected 81
Mechanical issue 56
Tidal volume fluctuations 52
Leak 42
No display or display failure 30
Break 25
Device alarm system issue 24
Suction issue 23
Loss of power 17
Computer software issue 16
Infusion or flow issue 13
Failure to deliver 12
Battery issue 11
Increase in pressure 11
Air leak 11
Excess flow or overinfusion 10
Device stops intermittently 9
Failure to power-up 8
Malfunction 8
Electrical issue 8
Defective Alarm 8
Inappropriate or unexpected reset 8
Data Issue 8
Power source issue 7
Blockage within device or device component 6
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
No flow 5
Operating system becomes non-functional 4
Dislodged or dislocated 4
Reset issue 4
Valve(s), defective 4
Sticking 4
Computer operating system issue 4
Failure to cycle 4
Failure to run on AC/DC 3
Improper gas output 3
Connection issue 3
No Information 3
Improper device output 3
Tipover 2
Moisture or humidity problem 2
Ventilation issue in device environment 2
Noise, Audible 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
No device output 2
Loose or intermittent connection 2
Inflation issue 2
Misconnection 2
Incorrect display 2
False device output 2
Fire 2
Low audible alarm 2
Disconnection 2
Connection error 2
Application interface becomes non-functional or program exits abnormally 2
Decrease in suction 1
Deflation issue 1
Design/structure problem 1
Not audible alarm 1
Failure to convert to back-up 1
Battery failure 1
Component falling 1
Fluid leak 1
Gas delivery system failure 1
Fail-safe design failure 1
Failure, intermittent 1
Monitor failure 1
Nonstandard device or device component 1
Device emits odor 1
Image display error 1
Material separation 1
Unstable 1
Inaccurate delivery 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Defective item 1
Delivery system failure 1
Detachment of device or device component 1
Communication or transmission issue 1
Application program issue 1
Patient Data Issue 1
Not Applicable 1
Protective measure issue 1
No Known Device Problem 1
Mechanical jam 1
Improper flow or infusion 1
Electrical shorting 1
Device sensing issue 1
Total Device Problems 1289

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 3 4 1 2 1
Class II 1 5 2 7 0 2 2 0 3 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Accutron Inc I Oct-09-2012
2 Blease Medical Equipment, Ltd. II Apr-16-2010
3 Datex - Ohmeda, Inc II Oct-06-2008
4 Del Mar Reynolds Medical, Ltd. I Nov-20-2013
5 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
6 Draeger Medical Systems, Inc. II Sep-23-2010
7 Draeger Medical, Inc. I Dec-12-2015
8 Draeger Medical, Inc. II Jul-27-2015
9 Draeger Medical, Inc. I Oct-10-2013
10 Draeger Medical, Inc. II Oct-08-2008
11 Draeger Medical, Inc. II Sep-23-2008
12 Draeger Medical, Inc. II Jul-16-2008
13 GE Healthcare II Apr-02-2015
14 GE Healthcare II Jul-30-2009
15 GE Healthcare II Jun-23-2009
16 GE Healthcare, LLC I Oct-15-2013
17 GE Healthcare, LLC I Oct-15-2013
18 GE Healthcare, LLC II Sep-06-2013
19 GE Healthcare, LLC II Jun-03-2013
20 GE Healthcare, LLC II Oct-06-2010
21 GE Medical Systems, LLC II Apr-22-2016
22 GE Medical Systems, LLC II Apr-13-2016
23 GE Medical Systems, LLC II Jan-21-2016
24 Ge Healthcare, Llc I May-11-2010
25 MAQUET Inc. II Sep-07-2007
26 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
27 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
28 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
29 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
30 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
31 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
32 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
33 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
34 Penlon, Ltd. II Mar-26-2012
35 Philips Healthcare Inc. II Aug-24-2010
36 Spacelabs Healthcare, Llc II Dec-27-2010
37 Spacelabs Healthcare, Llc II Jul-29-2010

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