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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
ABBOTT POINT OF CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2019 141 141
2020 117 117
2021 147 147
2022 138 138
2023 178 178
2024 90 90

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 189 189
Non Reproducible Results 135 135
Low Test Results 92 92
High Readings 85 85
High Test Results 84 84
Low Readings 51 51
Insufficient Information 34 34
Incorrect Measurement 29 29
Output Problem 21 21
Erratic Results 14 14
No Device Output 14 14
Computer Software Problem 12 12
Patient Data Problem 11 11
False Negative Result 10 10
Use of Device Problem 7 7
Device Displays Incorrect Message 7 7
No Apparent Adverse Event 6 6
Unable to Obtain Readings 5 5
Electrical /Electronic Property Problem 4 4
Mechanical Problem 4 4
Smoking 4 4
Failure to Calibrate 4 4
Calibration Problem 4 4
Program or Algorithm Execution Failure 4 4
Data Problem 3 3
Fluid/Blood Leak 3 3
Product Quality Problem 3 3
Overheating of Device 3 3
Failure to Obtain Sample 3 3
Unintended Ejection 2 2
Leak/Splash 2 2
Coagulation in Device or Device Ingredient 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Optical Problem 2 2
Human-Device Interface Problem 2 2
Infusion or Flow Problem 2 2
Installation-Related Problem 1 1
Material Deformation 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Sensing Problem 1 1
Incomplete or Inadequate Connection 1 1
Fail-Safe Did Not Operate 1 1
Misassembly During Maintenance/Repair 1 1
Missing Test Results 1 1
Low pH 1 1
Ejection Problem 1 1
Unexpected Shutdown 1 1
Filling Problem 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Material Discolored 1 1
Display or Visual Feedback Problem 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Inability to Irrigate 1 1
Melted 1 1
Nonstandard Device 1 1
Device Difficult to Setup or Prepare 1 1
Retraction Problem 1 1
Short Fill 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 501 501
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 71 71
Insufficient Information 43 43
No Information 30 30
No Patient Involvement 11 11
Anemia 10 10
Abnormal Blood Gases 8 8
Cardiac Arrest 7 7
Respiratory Distress 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Exposure to Body Fluids 4 4
Diabetic Ketoacidosis 4 4
Respiratory Insufficiency 4 4
Vomiting 4 4
Sepsis 3 3
Fall 3 3
Hypoxia 3 3
Chest Pain 3 3
No Code Available 3 3
Needle Stick/Puncture 3 3
Respiratory Acidosis 2 2
Pregnancy 2 2
Convulsion/Seizure 2 2
Renal Impairment 2 2
Abdominal Pain 2 2
Hyperbilirubinemia 2 2
Hyperglycemia 2 2
Septic Shock 2 2
Brain Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Cardiogenic Shock 1 1
Jaundice 1 1
Electrolyte Imbalance 1 1
Unspecified Infection 1 1
Muscle Weakness 1 1
Nausea 1 1
Pain 1 1
Pneumonia 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Respiratory Distress Syndrome of Newborns 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Hypoventilation 1 1
Asthma 1 1
Biliary Cirrhosis 1 1
Congenital Defect/Deformity 1 1
Death 1 1
Diarrhea 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Pulmonary Emphysema 1 1
Unspecified Kidney or Urinary Problem 1 1
Limb Fracture 1 1
Osteomyelitis 1 1
Unspecified Vascular Problem 1 1
Multiple Organ Failure 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Lethargy 1 1
Chemical Exposure 1 1
Low Oxygen Saturation 1 1
Alteration In Body Temperature 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 Instrumentation Laboratory II Nov-21-2023
4 Radiometer America Inc II Feb-05-2019
5 Radiometer Medical ApS II Jul-24-2024
6 Radiometer Medical ApS II Jul-01-2022
7 Radiometer Medical ApS II Jun-15-2021
8 Radiometer Medical ApS II Jul-04-2020
9 Radiometer Medical ApS II Jun-29-2020
10 Radiometer Medical ApS II May-28-2020
11 Radiometer Medical ApS II May-01-2020
12 Radiometer Medical ApS II Apr-22-2020
13 Radiometer Medical ApS II Apr-08-2020
14 Siemens Healthcare Diagnostics Inc II Jun-26-2024
15 Siemens Healthcare Diagnostics Inc II Dec-21-2023
16 Siemens Healthcare Diagnostics Inc II Aug-28-2023
17 Siemens Healthcare Diagnostics Inc II Mar-03-2023
18 Siemens Healthcare Diagnostics Inc II Jul-12-2022
19 Siemens Healthcare Diagnostics Inc II Jun-26-2020
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