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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device analyzer, gas, carbon-dioxide, gaseous-phase
Product CodeCCK
Regulation Number 868.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CMI HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
ENDURE INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIPINES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  1.  K161860  TG-970P CO2 Sensor Kit
  2.  K171765  Nihon Kohden CO2 Monitor
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORIDION MEDICAL 1987 LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
SOUTHMEDIC INC.
  SUBSTANTIALLY EQUIVALENT 1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENTURE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 58 58
2018 63 63
2019 141 141
2020 2302 2302
2021 2272 2272
2022 2475 2475
2023 1637 1637
2024 474 474

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3229 3229
Communication or Transmission Problem 2277 2277
Crack 2200 2200
Appropriate Term/Code Not Available 944 944
Corroded 904 904
Failure to Calibrate 823 823
Incorrect, Inadequate or Imprecise Result or Readings 734 734
Computer Software Problem 564 564
Device Alarm System 556 556
Contamination 509 509
Failure of Device to Self-Test 469 469
No Device Output 457 457
No Apparent Adverse Event 409 409
Loose or Intermittent Connection 396 396
Calibration Problem 350 350
Circuit Failure 298 298
Insufficient Information 295 295
Output Problem 220 220
Device Sensing Problem 184 184
Physical Resistance/Sticking 115 115
Failure to Read Input Signal 107 107
Display Difficult to Read 77 77
Display or Visual Feedback Problem 73 73
Application Program Freezes, Becomes Nonfunctional 61 61
Unable to Obtain Readings 55 55
Misassembled 49 49
Incorrect Measurement 41 41
Failure to Power Up 37 37
Peeled/Delaminated 37 37
Pumping Stopped 37 37
High Readings 32 32
Low Readings 32 32
Naturally Worn 28 28
Degraded 27 27
Application Program Problem 26 26
Failure to Cycle 25 25
Electrical /Electronic Property Problem 24 24
Power Problem 22 22
Gas Output Problem 19 19
Mechanical Problem 19 19
Temperature Problem 18 18
Image Display Error/Artifact 17 17
Device Operates Differently Than Expected 16 16
Device Markings/Labelling Problem 15 15
No Display/Image 15 15
Erratic or Intermittent Display 13 13
Device Displays Incorrect Message 13 13
Use of Device Problem 12 12
False Alarm 12 12
No Audible Alarm 12 12
Noise, Audible 12 12
Unexpected Shutdown 12 12
Failure to Sense 11 11
Defective Device 11 11
Device Stops Intermittently 10 10
Device Ingredient or Reagent Problem 10 10
Defective Alarm 10 10
Defective Component 9 9
Obstruction of Flow 9 9
Mechanics Altered 8 8
Application Program Version or Upgrade Problem 7 7
Battery Problem 7 7
Component Missing 7 7
Failure to Deliver 7 7
Device Damaged Prior to Use 6 6
Device Inoperable 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Smoking 6 6
Material Split, Cut or Torn 6 6
Data Problem 5 5
Suction Failure 5 5
Inaccurate Information 5 5
Partial Blockage 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Operational Issue 5 5
Device Issue 5 5
Invalid Sensing 5 5
Charging Problem 5 5
Failure to Align 5 5
Inaccurate Delivery 4 4
No Audible Prompt/Feedback 4 4
Electrical Power Problem 4 4
Filtration Problem 4 4
Deformation Due to Compressive Stress 4 4
Detachment of Device or Device Component 4 4
Infusion or Flow Problem 4 4
Disconnection 4 4
Sensing Intermittently 4 4
Nonstandard Device 4 4
Intermittent Loss of Power 4 4
Protective Measures Problem 4 4
Component Misassembled 4 4
Complete Loss of Power 3 3
Pressure Problem 3 3
Unclear Information 3 3
Missing Information 3 3
Unintended Application Program Shut Down 3 3
Intermittent Communication Failure 3 3
Material Fragmentation 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6151 6151
No Patient Involvement 3000 3000
No Known Impact Or Consequence To Patient 146 146
No Consequences Or Impact To Patient 143 143
Insufficient Information 109 109
No Information 88 88
Unintended Extubation 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 4 4
Foreign Body In Patient 3 3
Low Oxygen Saturation 3 3
Cardiac Arrest 3 3
Hypoxia 2 2
Death 2 2
Respiratory Distress 2 2
Partial thickness (Second Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Superficial (First Degree) Burn 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Death, Intrauterine Fetal 1 1
Hypersensitivity/Allergic reaction 1 1
Burn, Thermal 1 1
Lethargy 1 1
Pressure Sores 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Laceration(s) 1 1
Pain 1 1
Perforation 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Aug-30-2019
2 Covidien Llc II Dec-01-2020
3 GE Healthcare, LLC I Jan-10-2020
4 Oridion Medical 1987 Ltd. II Oct-03-2018
5 Smiths Medical ASD Inc. II Jul-06-2018
6 Southmedic, Inc. II Jul-24-2021
7 Southmedic, Inc. II Jan-25-2018
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