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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 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 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTROS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIOPTIX, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 24 24
2018 38 38
2019 104 104
2020 50 50
2021 27 27
2022 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 88 88
Incorrect Measurement 47 47
Incorrect, Inadequate or Imprecise Resultor Readings 35 35
High Readings 21 21
Patient Device Interaction Problem 16 16
Contamination /Decontamination Problem 14 14
Failure to Analyze Signal 10 10
Sensing Intermittently 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Loss of or Failure to Bond 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Use of Device Problem 4 4
Device Damaged Prior to Use 4 4
Output Problem 4 4
Temperature Problem 4 4
Device Operates Differently Than Expected 4 4
Detachment of Device or Device Component 3 3
False Reading From Device Non-Compliance 3 3
Material Integrity Problem 3 3
Image Display Error/Artifact 2 2
Device Emits Odor 2 2
Thermal Decomposition of Device 2 2
Defective Component 2 2
Device Alarm System 2 2
Failure to Power Up 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Connection Problem 1 1
Device Sensing Problem 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
Device Slipped 1 1
Device Stops Intermittently 1 1
Erratic or Intermittent Display 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 136 136
No Clinical Signs, Symptoms or Conditions 35 35
No Patient Involvement 20 20
No Known Impact Or Consequence To Patient 18 18
No Information 13 13
Pressure Sores 12 12
Burn(s) 11 11
Injury 10 10
Skin Irritation 5 5
Death 4 4
Infarction, Cerebral 3 3
Insufficient Information 3 3
Low Oxygen Saturation 2 2
Swelling 2 2
Erythema 2 2
Hemorrhage, Cerebral 1 1
Inflammation 1 1
Ischemia 1 1
Neurological Deficit/Dysfunction 1 1
Paresis 1 1
Pulmonary Edema 1 1
Rash 1 1
Complaint, Ill-Defined 1 1
Ecchymosis 1 1
Edema 1 1
Burn, Thermal 1 1
Diaphoresis 1 1
Myocarditis 1 1
No Code Available 1 1
Not Applicable 1 1
Bruise/Contusion 1 1

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