• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 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
  1.  K844012  OHMEDA ANESTHESIA RECORD KEEPER
  2.  K844849  OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
  3.  K850648  OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
  4.  K862831  MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
  5.  K863207  OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
  6.  K875350  OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
  7.  K882489  REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
  8.  K890410  REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
  9.  K893780  OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
  10.  K894309  OHMEDA MODULUS CD ANESTHESIA SYSTEM
  11.  K901117  OHMEDA UNIVERSAL PAC
  12.  K901119  OHMEDA MODULUS CD ANESTHESIA SYSTEM
  13.  K905635  OHMEDA MODULUS CD ANESTHESIA SYSTEM
  14.  K921742  OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
  15.  K946127  OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
  16.  K965041  OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SY ...
  17.  K973896  OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
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 400
Device displays error message 236
Device operates differently than expected 166
Pressure issue 130
Device inoperable 100
Mechanical issue 96
Tidal volume fluctuations 71
Leak 59
Device alarm system issue 58
No display or display failure 40
Break 38
Suction issue 28
Infusion or flow issue 24
Loss of power 18
Computer software issue 16
Excess flow or overinfusion 13
Increase in pressure 13
Device stops intermittently 12
Failure to deliver 12
Sticking 11
Air leak 11
Inappropriate or unexpected reset 11
Battery issue 11
Data Issue 11
Electrical issue 9
Defective Alarm 8
Blockage within device or device component 8
Failure to power-up 8
Malfunction 8
Reset issue 7
Power source issue 7
Operating system becomes non-functional 6
No flow 5
Other (for use when an appropriate device code cannot be identified) 5
Defective component 5
Computer operating system issue 5
Connection issue 4
Valve(s), defective 4
Failure to cycle 4
Improper gas output 4
Improper device output 4
Dislodged or dislocated 4
Failure of device to self-test 3
No Information 3
Incorrect display 3
Component falling 3
Failure to run on AC/DC 3
Use of Device Issue 3
Improper or incorrect procedure or method 2
No device output 2
Misconnection 2
Low audible alarm 2
Not audible alarm 2
Connection error 2
Decrease in suction 2
Application interface becomes non-functional or program exits abnormally 2
Disconnection 2
False device output 2
Fire 2
Inflation issue 2
Loose or intermittent connection 2
Ventilation issue in device environment 2
Moisture or humidity problem 2
Noise, Audible 2
Tipover 2
Improper flow or infusion 1
No Known Device Problem 1
No Pressure 1
Mechanical jam 1
Human-Device Interface Issue 1
Electrical shorting 1
Communication or transmission issue 1
Device sensing issue 1
Patient Data Issue 1
Protective measure issue 1
Not Applicable 1
Image display error 1
Fail-safe design failure 1
Failure, intermittent 1
Fluid leak 1
Gas delivery system failure 1
Deflation issue 1
Design/structure problem 1
Crack 1
Alarm not visible 1
Failure to convert to back-up 1
Battery failure 1
Detachment of device component 1
Monitor failure 1
Nonstandard device or device component 1
Device emits odor 1
Material separation 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Arcing 1
Defective item 1
Delivery system failure 1
Total Device Problems 1777

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

-
-