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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description Carbon dioxide gas analyzer.
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 5
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HUDSON RESPIRATORY CARE
  SUBSTANTIALLY EQUIVALENT 1
ICOR
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INVIVO
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 3
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 5
MAXTEC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL RESEARCH LAB., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 11
NONIN
  SUBSTANTIALLY EQUIVALENT 1
NOVAMETRIX
  SUBSTANTIALLY EQUIVALENT 5
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 2
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 62
Device inoperable 22
Device stops intermittently 15
Failure to calibrate 12
Device operates differently than expected 8
Output issue 6
Incorrect or inadequate result 4
Smoking 3
Calibration error 2
Incorrect measurement 2
No Known Device Problem 2
Spark 2
Malfunction 2
Defective item 1
No code available 1
Migration of device or device component 1
Occlusion within device 1
Unable to obtain readings 1
Intermittent continuity 1
Degraded 1
Disconnection 1
Electrical issue 1
False negative result 1
Restricted flowrate 1
Device alarm system issue 1
Failure to sense 1
Material separation 1
Fitting problem 1
Out-of-box failure 1
Device Issue 1
Total Device Problems 159

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

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Dec-21-2015
2 Covidien Limited I Sep-08-2009
3 GE Healthcare, LLC I Jul-18-2014
4 Medtronic I May-12-2016
5 Oridion Medical 1987 Ltd. II Mar-30-2012
6 Oridion Medical 1987 Ltd. II Mar-29-2012
7 Oridion Medical 1987 Ltd. I May-25-2011
8 Oridion Medical 1987 Ltd. II Jul-13-2010
9 Oridion Medical 1987 Ltd. II Sep-21-2009
10 Philips Healthcare Inc. I May-26-2011
11 Philips Healthcare Inc. II Apr-08-2010
12 SALTER LABS II Nov-19-2013
13 SALTER LABS II Jun-27-2012
14 SALTER LABS II Jan-11-2012
15 Salter Laboratories, Division of Regulatory Affairs II May-23-2011
16 Salter Laboratories, Division of Regulatory Affairs II May-20-2011
17 Smiths Medical ASD, Inc. II May-29-2015
18 Smiths Medical ASD, Inc. I Mar-29-2013
19 Smiths Medical PM, Inc. II Mar-02-2010
20 Smiths Medical PM, Inc. II May-15-2009
21 Ventlab LLC II Jun-01-2016

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