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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 5
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 3
BODIMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHRONISENSE MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  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
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEADTEK RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
NONIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
OWLET BABY CARE, INC.
  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 BRAV ELECTRONIC TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CORERAY TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 2
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 2
SHENZHEN WITLEAF MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YIMI LIFE-TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG 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
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WESPER INC.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN ACURIO INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
XINKANG MEDICAL INSTRUMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 693 693
2019 549 549
2020 426 426
2021 553 553
2022 479 479
2023 271 271

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 433 433
Sensing Intermittently 317 317
Low Readings 313 313
Display or Visual Feedback Problem 234 234
Device Alarm System 177 177
Inappropriate or Unexpected Reset 171 171
High Readings 131 131
Break 130 130
Patient Device Interaction Problem 88 88
Crack 87 87
Unexpected Shutdown 81 81
Corroded 72 72
No Audible Alarm 69 69
Incorrect, Inadequate or Imprecise Result or Readings 68 68
Contamination /Decontamination Problem 64 64
Image Display Error/Artifact 62 62
Unable to Obtain Readings 51 51
Temperature Problem 47 47
Communication or Transmission Problem 41 41
Poor Quality Image 37 37
Appropriate Term/Code Not Available 36 36
Adverse Event Without Identified Device or Use Problem 32 32
Noise, Audible 31 31
Patient-Device Incompatibility 30 30
Failure to Power Up 28 28
Circuit Failure 28 28
Contamination 27 27
No Display/Image 27 27
Battery Problem 27 27
Defective Device 25 25
Device Displays Incorrect Message 24 24
Failure to Analyze Signal 21 21
Loose or Intermittent Connection 20 20
Insufficient Information 20 20
Material Integrity Problem 19 19
Defective Alarm 19 19
Mechanical Problem 18 18
Failure To Run On AC/DC 17 17
No Apparent Adverse Event 17 17
Erratic or Intermittent Display 16 16
Failure to Read Input Signal 16 16
Device Stops Intermittently 15 15
Failure to Sense 15 15
Computer Software Problem 15 15
Charging Problem 15 15
Biological Environmental Factor 14 14
Device Damaged Prior to Use 14 14
Defective Component 14 14
Use of Device Problem 14 14
Output Problem 13 13
Device Operates Differently Than Expected 12 12
Sparking 11 11
Power Problem 11 11
Overheating of Device 11 11
Display Difficult to Read 11 11
Delayed Program or Algorithm Execution 11 11
Missing Information 10 10
Device Emits Odor 10 10
Device Markings/Labelling Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Sensing Problem 8 8
Material Separation 8 8
Premature Discharge of Battery 8 8
Material Split, Cut or Torn 7 7
Inaccurate Information 7 7
Application Program Freezes, Becomes Nonfunctional 6 6
No Visual Prompts/Feedback 6 6
Deformation Due to Compressive Stress 6 6
Ambient Noise Problem 6 6
Disconnection 6 6
Smoking 6 6
No Device Output 6 6
Peeled/Delaminated 6 6
Failure to Run on Battery 6 6
Physical Resistance/Sticking 5 5
Human-Device Interface Problem 5 5
Material Deformation 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Component Missing 4 4
Electrical /Electronic Property Problem 4 4
Loss of or Failure to Bond 4 4
Failure to Charge 3 3
False Alarm 3 3
False Reading From Device Non-Compliance 3 3
Fire 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Low Test Results 3 3
Connection Problem 3 3
Failure of Device to Self-Test 3 3
Protective Measures Problem 3 3
Mechanics Altered 3 3
Device Fell 3 3
Data Problem 3 3
Separation Problem 3 3
Erratic Results 2 2
Key or Button Unresponsive/not Working 2 2
Naturally Worn 2 2
Failure to Shut Off 2 2
High Test Results 2 2
Malposition of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1200 1200
No Clinical Signs, Symptoms or Conditions 1040 1040
No Patient Involvement 228 228
Insufficient Information 89 89
Pressure Sores 85 85
No Known Impact Or Consequence To Patient 77 77
Burn(s) 59 59
Death 38 38
Injury 32 32
No Information 23 23
Low Oxygen Saturation 22 22
Skin Irritation 14 14
Unspecified Tissue Injury 14 14
Superficial (First Degree) Burn 13 13
Tissue Damage 12 12
Burn, Thermal 10 10
Blister 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Erythema 8 8
Rash 7 7
Laceration(s) 5 5
Hypoxia 4 4
Inflammation 4 4
Cyanosis 4 4
Cardiac Arrest 4 4
Partial thickness (Second Degree) Burn 4 4
Skin Erosion 4 4
Tissue Breakdown 3 3
Bradycardia 3 3
Skin Discoloration 3 3
Ulcer 3 3
Pain 3 3
Respiratory Distress 2 2
Burning Sensation 2 2
Swelling 2 2
Bruise/Contusion 2 2
Dyspnea 2 2
Electric Shock 2 2
High Oxygen Saturation 2 2
Respiratory Failure 2 2
Full thickness (Third Degree) Burn 2 2
Not Applicable 2 2
Convulsion/Seizure 2 2
No Code Available 2 2
Skin Inflammation/ Irritation 2 2
Nodule 1 1
Missing Value Reason 1 1
Increased Sensitivity 1 1
Skin Burning Sensation 1 1
Skin Disorders 1 1
Heart Failure/Congestive Heart Failure 1 1
Respiratory Arrest 1 1
Joint Contracture 1 1
Increased Respiratory Rate 1 1
Deformity/ Disfigurement 1 1
Ventilator Dependent 1 1
Reaction 1 1
Coma 1 1
Irritability 1 1
Bronchopneumonia 1 1
Diminished Pulse Pressure 1 1
Discomfort 1 1
Hematoma 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Anemia 1 1
Anoxia 1 1
Apnea 1 1
Asthma 1 1
Tachycardia 1 1
Septic Shock 1 1
Paralysis 1 1
Pneumonia 1 1
Undesired Nerve Stimulation 1 1
Unintended Extubation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Masimo Corporation II Jun-21-2023
2 Oridion Medical 1987 Ltd. II Oct-03-2018
3 Xhale Assurance, Inc. II Jul-30-2019
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