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TPLC
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show TPLC since
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2023
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Device
oximeter, tissue saturation
Product Code
MUD
Regulation Number
870.2700
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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