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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 3
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 6
NONIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORANTECH 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 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 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 1
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 3
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 555 555
2022 479 479

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 419 419
Sensing Intermittently 299 299
Low Readings 283 283
Display or Visual Feedback Problem 232 232
Device Alarm System 163 163
Inappropriate or Unexpected Reset 161 161
Break 128 128
High Readings 125 125
Crack 86 86
Corroded 72 72
Patient Device Interaction Problem 67 67
No Audible Alarm 67 67
Contamination /Decontamination Problem 64 64
Incorrect, Inadequate or Imprecise Result or Readings 62 62
Image Display Error/Artifact 46 46
Unable to Obtain Readings 42 42
Communication or Transmission Problem 39 39
Poor Quality Image 35 35
Appropriate Term/Code Not Available 35 35
Temperature Problem 34 34
Noise, Audible 28 28
Contamination 27 27
Battery Problem 26 26
Failure to Power Up 26 26
Circuit Failure 26 26
No Display/Image 24 24
Defective Device 21 21
Device Displays Incorrect Message 21 21
Loose or Intermittent Connection 20 20
Material Integrity Problem 19 19
Mechanical Problem 18 18
Insufficient Information 18 18
Failure To Run On AC/DC 17 17
Defective Alarm 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Unexpected Shutdown 17 17
Patient-Device Incompatibility 16 16
Failure to Read Input Signal 16 16
Device Stops Intermittently 15 15
Charging Problem 15 15
Failure to Sense 15 15
Computer Software Problem 15 15
Failure to Analyze Signal 15 15
Erratic or Intermittent Display 14 14
No Apparent Adverse Event 14 14
Biological Environmental Factor 14 14
Defective Component 13 13
Output Problem 13 13
Device Operates Differently Than Expected 12 12
Sparking 11 11
Display Difficult to Read 11 11
Overheating of Device 11 11
Use of Device Problem 10 10
Device Damaged Prior to Use 10 10
Power Problem 10 10
Missing Information 10 10
Device Emits Odor 10 10
Device Markings/Labelling Problem 9 9
Premature Discharge of Battery 8 8
Therapeutic or Diagnostic Output Failure 7 7
Material Separation 7 7
Delayed Program or Algorithm Execution 7 7
Inaccurate Information 6 6
No Visual Prompts/Feedback 6 6
Device Sensing Problem 6 6
Peeled/Delaminated 6 6
Deformation Due to Compressive Stress 6 6
No Device Output 6 6
Ambient Noise Problem 6 6
Disconnection 6 6
Material Split, Cut or Torn 5 5
Physical Resistance/Sticking 5 5
Human-Device Interface Problem 5 5
Component Missing 4 4
Smoking 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Electrical /Electronic Property Problem 4 4
Failure to Run on Battery 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Mechanics Altered 3 3
Connection Problem 3 3
Loss of or Failure to Bond 3 3
Failure to Charge 3 3
Separation Problem 3 3
False Reading From Device Non-Compliance 3 3
Protective Measures Problem 3 3
Device Fell 3 3
Data Problem 3 3
Low Test Results 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
False Alarm 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Failure to Advance 2 2
Failure of Device to Self-Test 2 2
Material Deformation 2 2
Fire 2 2
Erratic Results 2 2
Melted 2 2
Labelling, Instructions for Use or Training Problem 2 2
Failure to Align 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 844 844
No Patient Involvement 229 229
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 68 68
Pressure Sores 59 59
Burn(s) 51 51
Death 38 38
Injury 32 32
No Information 23 23
Low Oxygen Saturation 19 19
Skin Irritation 14 14
Tissue Damage 12 12
Unspecified Tissue Injury 10 10
Burn, Thermal 10 10
Blister 7 7
Superficial (First Degree) Burn 7 7
Rash 7 7
Erythema 5 5
Laceration(s) 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cyanosis 4 4
Skin Erosion 4 4
Hypoxia 4 4
Cardiac Arrest 4 4
Pain 3 3
Tissue Breakdown 3 3
Partial thickness (Second Degree) Burn 3 3
Bradycardia 3 3
Bruise/Contusion 2 2
No Code Available 2 2
Electric Shock 2 2
Not Applicable 2 2
Swelling 2 2
Inflammation 2 2
Respiratory Failure 2 2
Convulsion/Seizure 2 2
Ulcer 2 2
Full thickness (Third Degree) Burn 2 2
High Oxygen Saturation 2 2
Respiratory Distress 2 2
Burning Sensation 2 2
Discomfort 1 1
Tachycardia 1 1
Reaction 1 1
Paralysis 1 1
Pneumonia 1 1
Undesired Nerve Stimulation 1 1
Chest Pain 1 1
Hyperventilation 1 1
Anoxia 1 1
Asthma 1 1
Nodule 1 1
Deformity/ Disfigurement 1 1
Coma 1 1
Anemia 1 1
Cardiopulmonary Arrest 1 1
Heart Failure/Congestive Heart Failure 1 1
Unintended Extubation 1 1
Increased Sensitivity 1 1
Septic Shock 1 1
Dyspnea 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Apnea 1 1
Diminished Pulse Pressure 1 1
Missing Value Reason 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Irritability 1 1
Bronchopneumonia 1 1
Increased Respiratory Rate 1 1

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