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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
Product CodeCHL
Regulation Number 862.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OPTI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 206 206
2018 174 174
2019 141 141
2020 117 117
2021 147 147
2022 122 122

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 267 267
Non Reproducible Results 145 145
Low Test Results 78 78
High Readings 67 67
Incorrect Or Inadequate Test Results 67 67
High Test Results 65 65
Use of Device Problem 36 36
Low Readings 32 32
Insufficient Information 22 22
Patient Data Problem 22 22
Incorrect Measurement 20 20
False Positive Result 15 15
Erratic Results 14 14
Output Problem 13 13
Adverse Event Without Identified Device or Use Problem 11 11
False Negative Result 10 10
Computer Software Problem 10 10
Fluid/Blood Leak 7 7
Device Displays Incorrect Message 6 6
Device Operates Differently Than Expected 6 6
Failure to Calibrate 5 5
No Apparent Adverse Event 5 5
Electrical /Electronic Property Problem 5 5
Mechanical Problem 5 5
Smoking 4 4
Device Issue 4 4
Leak/Splash 4 4
False Reading From Device Non-Compliance 4 4
Data Problem 4 4
Unintended Ejection 3 3
Coagulation in Device or Device Ingredient 3 3
No Device Output 2 2
Overheating of Device 2 2
Connection Problem 2 2
Missing Test Results 2 2
Infusion or Flow Problem 2 2
Application Security Problem 2 2
Program or Algorithm Execution Failure 2 2
Fail-Safe Did Not Operate 1 1
Misassembly During Maintenance/Repair 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Calibration Problem 1 1
Computer System Security Problem 1 1
Failure to Obtain Sample 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Noise, Audible 1 1
Low pH 1 1
Ejection Problem 1 1
Unexpected Shutdown 1 1
Device Handling Problem 1 1
Appropriate Term/Code Not Available 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Optical Problem 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Problem: Parameter Calculation Error 1 1
Unable to Obtain Readings 1 1
Nonstandard Device 1 1
Short Fill 1 1
Suction Problem 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Break 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Display Difficult to Read 1 1
Filling Problem 1 1
Loose or Intermittent Connection 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 273 273
No Clinical Signs, Symptoms or Conditions 247 247
No Known Impact Or Consequence To Patient 145 145
No Information 70 70
Insufficient Information 37 37
No Patient Involvement 21 21
Abnormal Blood Gases 21 21
No Code Available 14 14
Anemia 11 11
Respiratory Distress 10 10
Death 9 9
Not Applicable 6 6
Chest Pain 5 5
Exposure to Body Fluids 5 5
Hyperbilirubinemia 5 5
Septic Shock 5 5
Diabetic Ketoacidosis 4 4
Cardiac Arrest 4 4
Pneumonia 3 3
Respiratory Failure 3 3
Patient Problem/Medical Problem 3 3
Therapeutic Response, Increased 2 2
Premature Labor 2 2
Pregnancy 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Needle Stick/Puncture 2 2
Renal Failure 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Hyperglycemia 2 2
High Blood Pressure/ Hypertension 2 2
Hypoxia 2 2
Fall 2 2
Dyspnea 2 2
Abdominal Pain 2 2
Renal Impairment 2 2
Limb Fracture 1 1
Bronchitis 1 1
Burn(s) 1 1
Aneurysm 1 1
Apnea 1 1
Asthma 1 1
Atherosclerosis 1 1
Biliary Cirrhosis 1 1
Non specific EKG/ECG Changes 1 1
Pulmonary Emphysema 1 1
Fever 1 1
Unspecified Infection 1 1
Inflammation 1 1
Muscle Weakness 1 1
Hypoglycemia 1 1
Hypoventilation 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures 1 1
Sepsis 1 1
Chest Tightness/Pressure 1 1
Hernia 1 1
Cardiogenic Shock 1 1
Increased Respiratory Rate 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Lethargy 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Sore Throat 1 1
Spinal Cord Injury 1 1
Bronchopneumonia 1 1
Vomiting 1 1
Jaundice 1 1
Heart Failure 1 1
Brain Injury 1 1
Multiple Organ Failure 1 1
Cancer 1 1
Convulsion/Seizure 1 1
Rectal Anastomotic Leakage 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Low Oxygen Saturation 1 1
Respiratory Acidosis 1 1
Alteration In Body Temperature 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Jan-19-2021
2 Abbott Point Of Care Inc. II Feb-18-2020
3 Abbott Point Of Care Inc. II Dec-14-2018
4 Nova Biomedical Corporation II Jul-13-2017
5 Radiometer America Inc II Feb-05-2019
6 Radiometer America Inc II Dec-22-2018
7 Radiometer America Inc II Dec-08-2017
8 Radiometer America Inc II Mar-14-2017
9 Radiometer Medical ApS II Jul-01-2022
10 Radiometer Medical ApS II Jun-15-2021
11 Radiometer Medical ApS II Jul-04-2020
12 Radiometer Medical ApS II Jun-29-2020
13 Radiometer Medical ApS II May-28-2020
14 Radiometer Medical ApS II May-01-2020
15 Radiometer Medical ApS II Apr-22-2020
16 Radiometer Medical ApS II Apr-08-2020
17 Radiometer Medical ApS II Mar-14-2018
18 Roche Diagnostics Operations, Inc. II Jan-23-2017
19 Siemens Healthcare Diagnostics Inc II Jul-12-2022
20 Siemens Healthcare Diagnostics Inc II Jun-26-2020
21 Siemens Healthcare Diagnostics Inc II May-05-2017
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