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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, tissue saturation
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
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
KENT IMAGING
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MIMOSA DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
MODULATED IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTROS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 38 38
2019 104 104
2020 50 50
2021 27 27
2022 52 52
2023 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 90 90
Incorrect, Inadequate or Imprecise Result or Readings 59 59
Incorrect Measurement 56 56
Patient Device Interaction Problem 29 29
High Readings 18 18
Adverse Event Without Identified Device or Use Problem 15 15
Patient-Device Incompatibility 14 14
Contamination /Decontamination Problem 14 14
Failure to Analyze Signal 11 11
Sensing Intermittently 9 9
Insufficient Information 8 8
Appropriate Term/Code Not Available 7 7
Loss of or Failure to Bond 6 6
Device Alarm System 5 5
Device Damaged Prior to Use 5 5
Temperature Problem 5 5
Output Problem 4 4
Image Display Error/Artifact 4 4
Use of Device Problem 4 4
Display or Visual Feedback Problem 3 3
False Reading From Device Non-Compliance 3 3
Material Integrity Problem 3 3
Detachment of Device or Device Component 3 3
Defective Component 2 2
Defective Device 2 2
Thermal Decomposition of Device 2 2
Erratic or Intermittent Display 2 2
Failure to Power Up 2 2
Device Emits Odor 2 2
Application Program Problem: Parameter Calculation Error 1 1
Device Slipped 1 1
Mechanical Problem 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Ambient Noise Problem 1 1
Battery Problem 1 1
Device Operates Differently Than Expected 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1
Inappropriate or Unexpected Reset 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Data Problem 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 131 131
No Clinical Signs, Symptoms or Conditions 83 83
Pressure Sores 35 35
No Patient Involvement 17 17
Burn(s) 14 14
Injury 10 10
No Known Impact Or Consequence To Patient 10 10
No Information 10 10
Insufficient Information 10 10
Unspecified Tissue Injury 5 5
Skin Irritation 5 5
Death 3 3
Inflammation 3 3
Infarction, Cerebral 2 2
Low Oxygen Saturation 2 2
Skin Tears 2 2
Burn, Thermal 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
No Code Available 1 1
Blister 1 1
Localized Skin Lesion 1 1
Bruise/Contusion 1 1
Swelling 1 1
Diaphoresis 1 1
Myocarditis 1 1
Neurological Deficit/Dysfunction 1 1
Paresis 1 1
Pulmonary Edema 1 1
Rash 1 1
Skin Discoloration 1 1
Ecchymosis 1 1
Edema 1 1
Hemorrhage, Cerebral 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Mar-30-2022
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