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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 22
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 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 1075
No code available 707
Device displays error message 331
Device alarm system issue 318
Leak 266
Pressure issue 215
Mechanical issue 213
Device inoperable 147
Suction issue 130
Tidal volume fluctuations 113
Break 83
Excess flow or overinfusion 59
No display or display failure 49
Infusion or flow issue 33
Sticking 32
Increase in pressure 22
Loss of power 21
Battery issue 20
Computer software issue 19
Air leak 14
Device stops intermittently 13
Failure to deliver 12
Defective Alarm 12
High Readings 12
Inappropriate or unexpected reset 11
Data Issue 11
Power source issue 10
Electrical issue 9
Blockage within device or device component 8
Malfunction 8
Failure to power-up 8
Reset issue 8
Dislodged or dislocated 8
Failure to calibrate 7
Not audible alarm 7
Improper gas output 6
Computer operating system issue 6
Improper flow or infusion 6
Operating system becomes non-functional 6
No flow 5
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
Use of Device Issue 5
Valve(s), defective 4
Alarm not visible 4
Incorrect display 4
Crack 4
Improper device output 4
Connection issue 4
Calibration issue 4
Device damaged prior to use 4
Tipover 3
Communication or transmission issue 3
Delivery system failure 3
Failure of device to self-test 3
No Known Device Problem 3
Noise, Audible 3
Failure to cycle 3
Deflation issue 3
Disconnection 3
Failure to run on AC/DC 3
Detachment of device component 3
Component falling 3
No device output 3
Inflation issue 3
Loose or intermittent connection 3
Incorrect measurement 2
Misconnection 2
Improper or incorrect procedure or method 2
Insufficient flow or underinfusion 2
Component missing 2
Inaccurate delivery 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
No Information 2
Output issue 2
Moisture or humidity problem 2
Gas leak 2
Human-Device Interface Issue 1
Failure to shut off 1
Electrical power problem 1
Electrical shorting 1
Low battery impedance 1
Mechanical jam 1
No Pressure 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
Total Device Problems 4183

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 2
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 May-24-2017
19 GE Healthcare, LLC II Dec-14-2016
20 GE Healthcare, LLC I Oct-15-2013
21 GE Healthcare, LLC I Oct-15-2013
22 GE Healthcare, LLC II Sep-06-2013
23 GE Healthcare, LLC II Jun-03-2013
24 GE Healthcare, LLC II Oct-06-2010
25 GE Medical Systems, LLC II Apr-22-2016
26 GE Medical Systems, LLC II Apr-13-2016
27 GE Medical Systems, LLC II Jan-21-2016
28 Ge Healthcare, Llc I May-11-2010
29 MAQUET Inc. II Sep-07-2007
30 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
31 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
32 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
33 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
34 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
35 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
36 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
37 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
38 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Dec-05-2008
39 Penlon, Ltd. II Mar-26-2012
40 Philips Healthcare Inc. II Aug-24-2010
41 Spacelabs Healthcare, Llc II Dec-27-2010
42 Spacelabs Healthcare, Llc II Jul-29-2010

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