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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
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOBEAT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 3
BODIMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHRONISENSE MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COFOE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GABI SMARTCARE SA
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANCOCK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XIAOOU 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 2
OWLET BABY CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.L.P. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPULSE CORPORATION
  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 CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY 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 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
SIBEL HEALTH INC.
  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
VYVO TECHNOLOGY CORP.(VT)
  SUBSTANTIALLY EQUIVALENT 1
WESPER INC.
  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
2019 549 549
2020 426 426
2021 553 553
2022 479 479
2023 392 392
2024 285 285

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 353 353
Low Readings 324 324
Sensing Intermittently 277 277
Device Alarm System 174 174
Unexpected Shutdown 151 151
High Readings 143 143
Display or Visual Feedback Problem 126 126
Inappropriate or Unexpected Reset 118 118
Break 116 116
Patient Device Interaction Problem 102 102
Crack 88 88
Image Display Error/Artifact 83 83
Incorrect, Inadequate or Imprecise Result or Readings 77 77
Temperature Problem 75 75
Corroded 72 72
Failure to Analyze Signal 57 57
Contamination /Decontamination Problem 52 52
Unable to Obtain Readings 45 45
Communication or Transmission Problem 43 43
No Audible Alarm 41 41
Appropriate Term/Code Not Available 38 38
Erratic or Intermittent Display 34 34
Adverse Event Without Identified Device or Use Problem 31 31
Noise, Audible 30 30
Failure to Power Up 30 30
Circuit Failure 28 28
Contamination 27 27
Patient-Device Incompatibility 27 27
Defective Device 24 24
No Apparent Adverse Event 22 22
Device Displays Incorrect Message 20 20
Mechanical Problem 19 19
Poor Quality Image 19 19
Failure to Read Input Signal 19 19
Device Damaged Prior to Use 17 17
No Display/Image 17 17
Battery Problem 17 17
Insufficient Information 14 14
Delayed Program or Algorithm Execution 14 14
Computer Software Problem 14 14
Use of Device Problem 14 14
Defective Component 13 13
Loose or Intermittent Connection 13 13
Failure to Sense 13 13
Defective Alarm 13 13
Charging Problem 13 13
Material Integrity Problem 12 12
Output Problem 11 11
Material Split, Cut or Torn 11 11
Display Difficult to Read 11 11
Missing Information 10 10
Device Markings/Labelling Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Material Separation 8 8
Overheating of Device 8 8
Premature Discharge of Battery 7 7
Inaccurate Information 7 7
Device Sensing Problem 7 7
Ambient Noise Problem 7 7
Deformation Due to Compressive Stress 6 6
Application Program Freezes, Becomes Nonfunctional 6 6
No Visual Prompts/Feedback 6 6
Loss of or Failure to Bond 6 6
Device Emits Odor 6 6
Peeled/Delaminated 6 6
Failure to Run on Battery 6 6
No Device Output 6 6
Smoking 5 5
Physical Resistance/Sticking 5 5
Human-Device Interface Problem 5 5
Power Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Deformation 5 5
Failure of Device to Self-Test 4 4
Data Problem 4 4
Device Fell 4 4
Disconnection 4 4
Electrical /Electronic Property Problem 3 3
Fire 3 3
Failure to Charge 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Separation Problem 3 3
Failure to Shut Off 3 3
Connection Problem 3 3
Protective Measures Problem 3 3
Mechanics Altered 3 3
Naturally Worn 2 2
Sparking 2 2
Malposition of Device 2 2
Erratic Results 2 2
Key or Button Unresponsive/not Working 2 2
Unintended Electrical Shock 2 2
Low Test Results 2 2
Failure to Calibrate 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Advance 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inadequate Instructions for Healthcare Professional 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1354 1354
No Consequences Or Impact To Patient 663 663
No Patient Involvement 184 184
Insufficient Information 159 159
Pressure Sores 85 85
Burn(s) 54 54
Death 32 32
Low Oxygen Saturation 30 30
No Known Impact Or Consequence To Patient 24 24
Injury 23 23
Unspecified Tissue Injury 18 18
Blister 17 17
No Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Superficial (First Degree) Burn 11 11
Skin Irritation 9 9
Erythema 7 7
Rash 6 6
Laceration(s) 5 5
Ulcer 5 5
Hypoxia 5 5
Burn, Thermal 5 5
Inflammation 4 4
Cardiac Arrest 4 4
Tissue Damage 4 4
Skin Erosion 4 4
Cyanosis 3 3
Skin Discoloration 3 3
Electric Shock 3 3
Partial thickness (Second Degree) Burn 3 3
Skin Inflammation/ Irritation 3 3
Skin Disorders 2 2
Convulsion/Seizure 2 2
Ventilator Dependent 2 2
High Oxygen Saturation 2 2
Respiratory Failure 2 2
Pain 2 2
Tachycardia 2 2
Burning Sensation 2 2
Bradycardia 2 2
Dyspnea 2 2
Hematoma 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Bruise/Contusion 1 1
Chest Pain 1 1
Abrasion 1 1
Anemia 1 1
Apnea 1 1
Asthma 1 1
Swelling 1 1
Paralysis 1 1
Pneumonia 1 1
Undesired Nerve Stimulation 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Increased Respiratory Rate 1 1
Reaction 1 1
Bronchopneumonia 1 1
Deformity/ Disfigurement 1 1
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Diminished Pulse Pressure 1 1
Tissue Breakdown 1 1
Heart Failure/Congestive Heart Failure 1 1
Respiratory Arrest 1 1
Joint Contracture 1 1
Increased Sensitivity 1 1
Skin Burning Sensation 1 1
Nodule 1 1
Unintended Extubation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Masimo Corporation II Apr-12-2024
2 Masimo Corporation II Jun-21-2023
3 Xhale Assurance, Inc. II Jul-30-2019
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