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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 oximeter, tissue saturation
Regulation Description Oximeter.
Product CodeMUD
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHRISTIE MEDICAL HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAMAMATSU PHOTONICS K.K.
  SUBSTANTIALLY EQUIVALENT 1
HYPERMED IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING
  SUBSTANTIALLY EQUIVALENT 1
KENT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
MESPERE LIFESCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
MIMOSA DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
MODULATED IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTROS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 9 9
2017 24 24
2018 38 38
2019 104 104
2020 50 50
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 84 84
Incorrect Measurement 43 43
Incorrect, Inadequate or Imprecise Resultor Readings 26 26
High Readings 16 16
Contamination /Decontamination Problem 14 14
Sensing Intermittently 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Analyze Signal 8 8
Patient Device Interaction Problem 7 7
Loss of or Failure to Bond 6 6
Device Operates Differently Than Expected 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Output Problem 4 4
Device Damaged Prior to Use 4 4
Improper or Incorrect Procedure or Method 3 3
Material Integrity Problem 3 3
False Reading From Device Non-Compliance 3 3
Detachment of Device or Device Component 3 3
Device Slipped 2 2
Use of Device Problem 2 2
Defective Device 2 2
Device Emits Odor 2 2
Device Handling Problem 2 2
Device Displays Incorrect Message 2 2
Device Stops Intermittently 2 2
Thermal Decomposition of Device 2 2
Erratic or Intermittent Display 1 1
Image Display Error/Artifact 1 1
Application Program Problem: Parameter Calculation Error 1 1
Device Alarm System 1 1
Defective Component 1 1
Connection Problem 1 1
Device Sensing Problem 1 1
Inappropriate or Unexpected Reset 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Battery Problem 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Patient-Device Incompatibility 1 1
Display or Visual Feedback Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 137 137
No Patient Involvement 20 20
No Known Impact Or Consequence To Patient 18 18
No Information 13 13
Injury 10 10
Burn(s) 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Erythema 7 7
Pressure Sores 6 6
Skin Irritation 5 5
Death 4 4
Infarction, Cerebral 3 3
Bruise/Contusion 2 2
Edema 2 2
Burn, Thermal 2 2
Swelling 2 2
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Hemorrhage, Cerebral 1 1
Ischemia 1 1
Neurological Deficit/Dysfunction 1 1
Paresis 1 1
Rash 1 1
No Code Available 1 1
Myocarditis 1 1
Not Applicable 1 1
Pulmonary Edema 1 1
Tissue Damage 1 1
Complaint, Ill-Defined 1 1
Ecchymosis 1 1

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