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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
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
ABEON MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
BESMED HEALTH BUSINESS CORP.
  SUBSTANTIALLY EQUIVALENT 1
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CMI HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DISPO-MED (MALAYSIA) SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL AG & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE
  SUBSTANTIALLY EQUIVALENT 1
FLEXICARE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 4
INTERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIPINES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIPLUS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
MERCURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MONITOR MASK, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION CAPNOGRAPHY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 8
PHASEIN AB
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
PNEUMA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POM MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESPIRION, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
SEEBREATH AB
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TYLENOL MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTLAB CORP.
  SUBSTANTIALLY EQUIVALENT 1
VENTURE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 51 51
2015 114 114
2016 88 88
2017 58 58
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 212 212

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3146 3146
Communication or Transmission Problem 2135 2135
Crack 2132 2132
Appropriate Term/Code Not Available 943 943
Corroded 875 875
Failure to Calibrate 801 801
Incorrect, Inadequate or Imprecise Result or Readings 724 724
Computer Software Problem 564 564
Device Alarm System 544 544
Contamination 498 498
Failure of Device to Self-Test 465 465
No Device Output 452 452
No Apparent Adverse Event 406 406
Loose or Intermittent Connection 373 373
Calibration Problem 345 345
Circuit Failure 295 295
Insufficient Information 295 295
Output Problem 229 229
Device Sensing Problem 185 185
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 106 106
Device Displays Incorrect Message 85 85
Display Difficult to Read 75 75
Display or Visual Feedback Problem 73 73
Device Operates Differently Than Expected 66 66
Application Program Freezes, Becomes Nonfunctional 61 61
Unable to Obtain Readings 51 51
Misassembled 49 49
Incorrect Measurement 43 43
Failure to Power Up 37 37
Pumping Stopped 37 37
Device Inoperable 37 37
Peeled/Delaminated 36 36
Low Readings 32 32
High Readings 29 29
Degraded 28 28
Naturally Worn 28 28
Application Program Problem 26 26
Device Stops Intermittently 25 25
Failure to Cycle 25 25
Electrical /Electronic Property Problem 24 24
Power Problem 22 22
Gas Output Problem 21 21
Mechanical Problem 19 19
Image Display Error/Artifact 18 18
Temperature Problem 18 18
No Display/Image 16 16
Erratic or Intermittent Display 14 14
No Audible Alarm 14 14
False Alarm 13 13
Failure to Sense 13 13
Noise, Audible 13 13
Device Markings/Labelling Problem 12 12
Defective Device 11 11
Smoking 11 11
Use of Device Problem 11 11
Obstruction of Flow 10 10
Defective Alarm 10 10
Mechanics Altered 9 9
Unexpected Shutdown 9 9
Device Damaged Prior to Use 8 8
Component Missing 8 8
Device Ingredient or Reagent Problem 8 8
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Failure to Deliver 7 7
Material Integrity Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Deformation 6 6
Material Split, Cut or Torn 6 6
Defective Component 6 6
Sparking 6 6
Detachment of Device or Device Component 6 6
Device Operational Issue 5 5
Charging Problem 5 5
Invalid Sensing 5 5
Failure to Align 5 5
Incorrect Or Inadequate Test Results 5 5
Device Issue 5 5
Improper or Incorrect Procedure or Method 5 5
Partial Blockage 5 5
Thermal Decomposition of Device 5 5
Calibration Error 5 5
Material Discolored 5 5
Disconnection 5 5
Overheating of Device 5 5
Device Emits Odor 5 5
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Intermittent Loss of Power 4 4
Protective Measures Problem 4 4
Component Misassembled 4 4
Nonstandard Device 4 4
Occlusion Within Device 4 4
Sensing Intermittently 4 4
No Audible Prompt/Feedback 4 4
Inaccurate Delivery 4 4
Electrical Power Problem 4 4
Deformation Due to Compressive Stress 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5905 5905
No Patient Involvement 3020 3020
No Known Impact Or Consequence To Patient 319 319
No Consequences Or Impact To Patient 174 174
No Information 103 103
Insufficient Information 103 103
Unintended Extubation 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Cardiac Arrest 5 5
Low Oxygen Saturation 4 4
Foreign Body In Patient 4 4
Patient Problem/Medical Problem 3 3
Extubate 3 3
Death 3 3
Hypoxia 3 3
Perforation 3 3
Pneumothorax 3 3
No Code Available 3 3
Hypersensitivity/Allergic reaction 2 2
Unspecified Tissue Injury 2 2
Respiratory Distress 2 2
Vomiting 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Pain 1 1
Erythema 1 1
Death, Intrauterine Fetal 1 1
Pulmonary Embolism 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1
Reaction 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Burn, Thermal 1 1
Lethargy 1 1
Missed Dose 1 1
Pressure Sores 1 1
Anxiety 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Aug-30-2019
2 CareFusion 303, Inc. II Dec-21-2015
3 Covidien Limited I Sep-08-2009
4 Covidien Llc II Dec-01-2020
5 GE Healthcare, LLC I Jan-10-2020
6 GE Healthcare, LLC I Jul-18-2014
7 Medtronic I May-12-2016
8 Oridion Medical 1987 Ltd. II Oct-03-2018
9 Oridion Medical 1987 Ltd. II Mar-30-2012
10 Oridion Medical 1987 Ltd. II Mar-29-2012
11 Oridion Medical 1987 Ltd. I May-25-2011
12 Oridion Medical 1987 Ltd. II Jul-13-2010
13 Oridion Medical 1987 Ltd. II Sep-21-2009
14 Philips Healthcare Inc. I May-26-2011
15 Philips Healthcare Inc. II Apr-08-2010
16 SALTER LABS II Nov-19-2013
17 SALTER LABS II Jun-27-2012
18 SALTER LABS II Jan-11-2012
19 Salter Laboratories, Division of Regulatory Affairs II May-23-2011
20 Salter Laboratories, Division of Regulatory Affairs II May-20-2011
21 Smiths Medical ASD Inc. II Jul-06-2018
22 Smiths Medical ASD, Inc. II May-29-2015
23 Smiths Medical ASD, Inc. I Mar-29-2013
24 Smiths Medical PM, Inc. II Mar-02-2010
25 Smiths Medical PM, Inc. II May-15-2009
26 Southmedic, Inc. II Jul-24-2021
27 Southmedic, Inc. II Jan-25-2018
28 Ventlab LLC II Jun-01-2016
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