Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 187 187
Non Reproducible Results 135 135
High Readings 85 85
Low Test Results 82 82
High Test Results 79 79
Low Readings 50 50
Insufficient Information 32 32
Incorrect Measurement 27 27
Output Problem 21 21
Erratic Results 14 14
No Device Output 14 14
Patient Data Problem 11 11
False Negative Result 10 10
Computer Software Problem 8 8
Device Displays Incorrect Message 7 7
No Apparent Adverse Event 6 6
Use of Device Problem 6 6
Unable to Obtain Readings 5 5
Smoking 4 4
Failure to Calibrate 4 4
Electrical /Electronic Property Problem 4 4
Calibration Problem 4 4
Failure to Obtain Sample 3 3
Program or Algorithm Execution Failure 3 3
Data Problem 3 3
Mechanical Problem 3 3
Fluid/Blood Leak 3 3
Product Quality Problem 3 3
Overheating of Device 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
Date/Time-Related Software Problem 1 1
Defective Device 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
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
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 475 475
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 71 71
Insufficient Information 42 42
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
No Code Available 3 3
Pregnancy 2 2
Needle Stick/Puncture 2 2
Respiratory Acidosis 2 2
Convulsion/Seizure 2 2
Renal Impairment 2 2
Septic Shock 2 2
Brain Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Chest Pain 2 2
Abdominal Pain 2 2
Hyperbilirubinemia 2 2
Hyperglycemia 2 2
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
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
Unspecified Kidney or Urinary Problem 1 1
Limb Fracture 1 1
Osteomyelitis 1 1
Unspecified Vascular Problem 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
Multiple Organ Failure 1 1
Pancreatitis 1 1
Rectal Anastomotic Leakage 1 1
Increased Intra-Peritoneal Volume (IIPV) 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-01-2022
6 Radiometer Medical ApS II Jun-15-2021
7 Radiometer Medical ApS II Jul-04-2020
8 Radiometer Medical ApS II Jun-29-2020
9 Radiometer Medical ApS II May-28-2020
10 Radiometer Medical ApS II May-01-2020
11 Radiometer Medical ApS II Apr-22-2020
12 Radiometer Medical ApS II Apr-08-2020
13 Siemens Healthcare Diagnostics Inc II Dec-21-2023
14 Siemens Healthcare Diagnostics Inc II Aug-28-2023
15 Siemens Healthcare Diagnostics Inc II Mar-03-2023
16 Siemens Healthcare Diagnostics Inc II Jul-12-2022
17 Siemens Healthcare Diagnostics Inc II Jun-26-2020
-
-