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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode measurement, blood-gases (pco2, po2) and blood ph
Regulation Description Blood gases (PCO2, PO2) and blood pH test system.
Product CodeCHL
Regulation Number 862.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
NOVA
  SUBSTANTIALLY EQUIVALENT 4
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 2
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 55 55
2016 118 118
2017 206 206
2018 174 174
2019 141 141
2020 87 87

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 211 211
Incorrect Or Inadequate Test Results 101 101
Low Test Results 97 97
Non Reproducible Results 96 96
High Test Results 79 79
Use of Device Problem 33 33
Patient Data Problem 27 27
High Readings 25 25
Insufficient Information 21 21
False Positive Result 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Incorrect Measurement 13 13
Fluid Leak 12 12
False Negative Result 10 10
Device Operates Differently Than Expected 10 10
Low Readings 10 10
Improper or Incorrect Procedure or Method 9 9
Computer Software Problem 9 9
False Reading From Device Non-Compliance 8 8
Device Displays Incorrect Message 7 7
Electrical /Electronic Property Problem 5 5
Data Problem 4 4
Device Issue 4 4
Output Problem 4 4
Calibration Error 3 3
Coagulation in Device or Device Ingredient 3 3
Port 2 2
Sensor 2 2
Connection Problem 2 2
Leak/Splash 2 2
Application Security Problem 2 2
Calibration Problem 2 2
Device Handling Problem 2 2
Overheating of Device 2 2
Mechanical Problem 2 2
Unintended Ejection 2 2
Excess Flow or Over-Infusion 1 1
Electrode 1 1
Analyzer 1 1
Break 1 1
Burst Container or Vessel 1 1
Use of Incorrect Control Settings 1 1
Degraded 1 1
Nonstandard Device 1 1
Failure to Calibrate 1 1
Missing Test Results 1 1
Noise, Audible 1 1
Unexpected Shutdown 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Appropriate Term/Code Not Available 1 1
Computer System Security Problem 1 1
Split 1 1
Application Program Problem 1 1
Programming Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Component Or Accessory 1 1
Loose or Intermittent Connection 1 1
Application Program Problem: Parameter Calculation Error 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Failure to Obtain Sample 1 1
Device Sensing Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Chemical Problem 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Function Lid 1 1
Frame 1 1
Holder 1 1
Label 1 1
Syringe 1 1
Device Alarm System 1 1
Latch 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Image Display Error/Artifact 1 1
Display Difficult to Read 1 1
Low pH 1 1
Power Problem 1 1
Device Subassembly 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Fail-Safe Did Not Operate 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 393 393
No Known Impact Or Consequence To Patient 192 192
No Information 71 71
No Patient Involvement 24 24
Abnormal Blood Gases 22 22
No Code Available 15 15
Death 12 12
Respiratory Distress 11 11
Exposure to Body Fluids 7 7
Not Applicable 6 6
Septic Shock 5 5
Anemia 3 3
Respiratory Failure 3 3
Patient Problem/Medical Problem 3 3
Chest Pain 3 3
Hyperbilirubinemia 3 3
Pneumonia 3 3
Electrolyte Imbalance 3 3
Premature Labor 2 2
Diabetic Ketoacidosis 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Therapeutic Response, Increased 2 2
Hypoxia 2 2
Hyperglycemia 2 2
Hemorrhage/Bleeding 2 2
Cardiac Arrest 2 2
Abdominal Pain 2 2
Renal Failure 2 2
High Blood Pressure/ Hypertension 2 2
Pregnancy 2 2
Multiple Organ Failure 1 1
Cancer 1 1
Hypoventilation 1 1
Inflammation 1 1
Aneurysm 1 1
Burn(s) 1 1
Dyspnea 1 1
Pulmonary Emphysema 1 1
Fever 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Lethargy 1 1
Hernia 1 1
Hypernatremia 1 1
Spinal Cord Injury 1 1
Apnea 1 1
Atherosclerosis 1 1
Biliary Cirrhosis 1 1
Bronchitis 1 1
Hypoglycemia 1 1
Pain 1 1
Pneumothorax 1 1
Distress 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Seizures 1 1
Shock 1 1
Jaundice 1 1
Sore Throat 1 1
Bronchopneumonia 1 1
Chest Tightness/Pressure 1 1
Increased Respiratory Rate 1 1
Blood Loss 1 1
Heart Failure 1 1
Full thickness (Third Degree) Burn 1 1
Alteration In Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-18-2020
2 Abbott Point Of Care Inc. II Dec-14-2018
3 LifeHealth, LLC II Oct-23-2015
4 LifeHealth, LLC II Jun-27-2015
5 Nova Biomedical Corporation II Jul-13-2017
6 Radiometer America Inc II Feb-05-2019
7 Radiometer America Inc II Dec-22-2018
8 Radiometer America Inc II Dec-08-2017
9 Radiometer America Inc II Mar-14-2017
10 Radiometer America Inc II Dec-22-2016
11 Radiometer America Inc II Feb-03-2016
12 Radiometer America Inc II Jun-25-2015
13 Radiometer Medical ApS II Jul-04-2020
14 Radiometer Medical ApS II Jun-29-2020
15 Radiometer Medical ApS II May-28-2020
16 Radiometer Medical ApS II May-01-2020
17 Radiometer Medical ApS II Apr-22-2020
18 Radiometer Medical ApS II Apr-08-2020
19 Radiometer Medical ApS II Mar-14-2018
20 Roche Diagnostics Operations, Inc. II Jan-23-2017
21 Roche Diagnostics Operations, Inc. II Aug-21-2015
22 Roche Diagnostics Operations, Inc. II Aug-05-2015
23 Siemens Healthcare Diagnostics Inc II Jun-26-2020
24 Siemens Healthcare Diagnostics Inc II May-05-2017
25 Siemens Healthcare Diagnostics Inc II Sep-14-2016
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