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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
APK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING SAFE HEART TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
BIO-BEAT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOBEAT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUEPOINT MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANCOCK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XIAOOU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEADTEK RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
NONIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
OXITONE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
S.L.P. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BERRY ELECTRONIC TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AEON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CORERAY TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN FITFAITH TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN GREATMADE TECH LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN UPNMED EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YIMI LIFE-TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPRY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUREPULSE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
TAIWAN BIOPHOTONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRUE WEARABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESPER INC.
  SUBSTANTIALLY EQUIVALENT 1
XHALE, INC
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN ACURIO INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XINKANG MEDICAL INSTRUMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1191 1191
2018 693 693
2019 549 549
2020 426 426
2021 555 555
2022 203 203

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 687 687
Display or Visual Feedback Problem 418 418
Low Readings 302 302
Sensing Intermittently 272 272
Inappropriate or Unexpected Reset 204 204
Device Stops Intermittently 194 194
Device Alarm System 168 168
Device Operates Differently Than Expected 165 165
Break 132 132
Failure To Run On AC/DC 128 128
High Readings 123 123
No Audible Alarm 102 102
Crack 86 86
No Display/Image 74 74
Corroded 72 72
Unable to Obtain Readings 64 64
Contamination /Decontamination Problem 64 64
Patient Device Interaction Problem 55 55
Image Display Error/Artifact 42 42
Poor Quality Image 36 36
Appropriate Term/Code Not Available 36 36
Incorrect, Inadequate or Imprecise Resultor Readings 35 35
Battery Problem 34 34
Communication or Transmission Problem 33 33
Device Displays Incorrect Message 27 27
Contamination 27 27
Erratic or Intermittent Display 26 26
Circuit Failure 26 26
Loose or Intermittent Connection 25 25
Adverse Event Without Identified Device or Use Problem 25 25
Noise, Audible 24 24
Temperature Problem 23 23
Patient-Device Incompatibility 23 23
Device Sensing Problem 23 23
Failure to Power Up 23 23
Defective Device 20 20
Defective Alarm 19 19
Power Problem 18 18
Insufficient Information 18 18
Material Integrity Problem 16 16
No Apparent Adverse Event 15 15
Biological Environmental Factor 14 14
Failure to Sense 14 14
Failure to Read Input Signal 13 13
Sparking 13 13
Charging Problem 13 13
Output Problem 11 11
Failure to Analyze Signal 11 11
Display Difficult to Read 11 11
Computer Software Problem 11 11
Use of Device Problem 10 10
Device Emits Odor 10 10
Defective Component 10 10
Missing Information 10 10
Device Damaged Prior to Use 9 9
Overheating of Device 9 9
Device Markings/Labelling Problem 8 8
Therapeutic or Diagnostic Output Failure 7 7
Premature Discharge of Battery 7 7
Disconnection 6 6
Electrical /Electronic Property Problem 6 6
Peeled/Delaminated 6 6
Mechanical Problem 6 6
Smoking 6 6
Inappropriate/Inadequate Shock/Stimulation 6 6
No Device Output 6 6
Human-Device Interface Problem 6 6
Deformation Due to Compressive Stress 6 6
Material Split, Cut or Torn 5 5
Physical Resistance/Sticking 5 5
Nonstandard Device 5 5
False Reading From Device Non-Compliance 5 5
Thermal Decomposition of Device 4 4
Failure to Charge 4 4
Failure To Adhere Or Bond 4 4
Component Missing 4 4
Inaccurate Information 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Low Test Results 3 3
Ambient Noise Problem 3 3
Connection Problem 3 3
Device Fell 3 3
Unexpected Shutdown 3 3
Protective Measures Problem 3 3
Data Problem 3 3
Mechanics Altered 3 3
Manufacturing, Packaging or Shipping Problem 3 3
False Alarm 3 3
Loss of or Failure to Bond 3 3
Material Separation 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Device Difficult to Program or Calibrate 2 2
Melted 2 2
Leak/Splash 2 2
Failure to Run on Battery 2 2
Low Audible Alarm 2 2
Unintended Ejection 2 2
Fire 2 2
False Device Output 2 2
Material Deformation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1931 1931
No Clinical Signs, Symptoms or Conditions 608 608
No Known Impact Or Consequence To Patient 400 400
No Patient Involvement 295 295
Death 55 55
Burn(s) 53 53
Insufficient Information 53 53
Pressure Sores 50 50
Injury 35 35
No Information 35 35
Low Oxygen Saturation 22 22
Skin Irritation 16 16
Tissue Damage 13 13
Burn, Thermal 11 11
Respiratory Distress 8 8
Rash 7 7
Superficial (First Degree) Burn 7 7
Unspecified Tissue Injury 6 6
Electric Shock 6 6
Cardiac Arrest 6 6
Erythema 6 6
Cyanosis 5 5
Hypoxia 5 5
Laceration(s) 5 5
Tissue Breakdown 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Skin Tears 4 4
Partial thickness (Second Degree) Burn 3 3
No Code Available 3 3
Seizures 3 3
Burning Sensation 3 3
Bradycardia 3 3
Bruise/Contusion 2 2
Cardiopulmonary Arrest 2 2
Congestive Heart Failure 2 2
Anoxia 2 2
Swelling 2 2
Pain 2 2
Convulsion/Seizure 2 2
Full thickness (Third Degree) Burn 2 2
Not Applicable 2 2
High Oxygen Saturation 2 2
Respiratory Failure 2 2
Skin Erosion 2 2
Ulcer 2 2
Brain Injury 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Coma 1 1
Irritability 1 1
Bronchopneumonia 1 1
Increased Respiratory Rate 1 1
Diminished Pulse Pressure 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Foreign Body In Patient 1 1
Blister 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Missing Value Reason 1 1
Unintended Extubation 1 1
Paralysis 1 1
Pneumonia 1 1
Necrosis 1 1
Ischemia 1 1
Tachycardia 1 1
Septic Shock 1 1
Shock 1 1
Scarring 1 1
Aspiration/Inhalation 1 1
Asthma 1 1
Failure to Anastomose 1 1
Abrasion 1 1
Dyspnea 1 1
Hematoma 1 1
High Blood Pressure/ Hypertension 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Feb-02-2017
2 Merge Healthcare, Inc. II Jun-29-2017
3 Nonin Medical, Inc II Mar-28-2017
4 Oridion Medical 1987 Ltd. II Oct-03-2018
5 Xhale Assurance, Inc. II Jul-30-2019
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