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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, measurement, blood-pressure, non-invasive
Product CodeDXN
Regulation Number 870.1130
Device Class 2


Premarket Reviews
ManufacturerDecision
A&D COMPANY, LTD
  SUBSTANTIALLY EQUIVALENT 2
A&D COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
AGELESS HEALTH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL (SHENZHEN), INC
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 2
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARETAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CNSYSTEMS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
CONMO ELECTRONIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 4
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FINAPRES MEDICAL SYSTEMS B.V.
  SUBSTANTIALLY EQUIVALENT 1
FINAPRES MEDICAL SYSTEMS BV
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GMC INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 5
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
H4D SAS
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHSTATS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
HIGI SH LLC
  SUBSTANTIALLY EQUIVALENT 1
HONSUN(NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONSUN(NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
INBODY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT& SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
LD TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVEMETRIC (MEDICAL) S.A.
  SUBSTANTIALLY EQUIVALENT 1
LOTUSNINE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDITECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CARE MANAGEMENT SERVICES
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 10
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 8
PAR MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
QARDIO INC
  SUBSTANTIALLY EQUIVALENT 1
RGB MEDICAL DEVICES SA
  SUBSTANTIALLY EQUIVALENT 1
RUDOLF RIESTER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SECA GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMBEI TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIACOM TECHNOLOGY CO ., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KINGYIELD 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 PANGO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN PANGO ELECTRONIC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISIOMED GROUP SA
  SUBSTANTIALLY EQUIVALENT 1
VITA-COURSE TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
YA HORNG ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 90 90
2018 617 617
2019 96 96
2020 130 130
2021 162 162
2022 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 391 391
Incorrect, Inadequate or Imprecise Resultor Readings 289 289
Device Displays Incorrect Message 250 250
Output Problem 222 222
Device Operates Differently Than Expected 221 221
Incorrect Or Inadequate Test Results 174 174
Fluid Leak 156 156
High Test Results 122 122
Incorrect Measurement 54 54
Low Readings 42 42
No Audible Alarm 33 33
No Audible Prompt/Feedback 30 30
High Readings 27 27
Defective Device 26 26
No Device Output 26 26
Overheating of Device 20 20
Therapeutic or Diagnostic Output Failure 18 18
Failure to Pump 17 17
Smoking 15 15
Application Program Freezes, Becomes Nonfunctional 14 14
Fire 13 13
Break 11 11
Fracture 10 10
Loose or Intermittent Connection 9 9
Inflation Problem 9 9
Inaudible or Unclear Audible Prompt/Feedback 9 9
Appropriate Term/Code Not Available 9 9
Defective Component 8 8
Device Inoperable 8 8
Detachment of Device or Device Component 8 8
No Display/Image 8 8
Display or Visual Feedback Problem 8 8
Leak/Splash 7 7
Mechanical Problem 7 7
Computer Operating System Problem 7 7
Protective Measures Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 6 6
Sparking 6 6
Failure to Power Up 6 6
Electrical /Electronic Property Problem 6 6
Battery Problem 5 5
Device Fell 5 5
Physical Property Issue 5 5
Improper Alarm 4 4
Flare or Flash 4 4
Inadequate User Interface 4 4
Pressure Problem 4 4
Pumping Problem 4 4
Operating System Becomes Nonfunctional 4 4
Malposition of Device 4 4
Low Test Results 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4 4
Device Alarm System 4 4
Component Falling 3 3
Decrease in Pressure 3 3
Invalid Sensing 3 3
Unable to Obtain Readings 3 3
Power Problem 3 3
Infusion or Flow Problem 3 3
Electrical Shorting 3 3
Failure to Shut Off 3 3
Issue With Displayed Error Message 2 2
Improper Device Output 2 2
Gas Leak 2 2
Material Integrity Problem 2 2
Temperature Problem 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Device Stops Intermittently 2 2
Device Issue 2 2
Electrical Power Problem 2 2
Device Sensing Problem 2 2
Device Emits Odor 2 2
Crack 2 2
Material Discolored 2 2
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Deflation Problem 1 1
Unintended Power Up 1 1
Image Display Error/Artifact 1 1
Defective Alarm 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Detachment Of Device Component 1 1
Energy Output Problem 1 1
Loss of Power 1 1
Material Puncture/Hole 1 1
Melted 1 1
Moisture Damage 1 1
Poor Quality Image 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or SeparationProblem 1 1
Patient-Device Incompatibility 1 1
Application Network Problem 1 1
Application Program Problem 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Arcing 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 738 738
No Clinical Signs, Symptoms or Conditions 246 246
No Consequences Or Impact To Patient 77 77
No Patient Involvement 66 66
Insufficient Information 32 32
No Information 6 6
Dizziness 5 5
Pain 5 5
Cardiac Arrest 5 5
Fall 4 4
No Code Available 4 4
Syncope/Fainting 4 4
Bruise/Contusion 3 3
Hematoma 3 3
Hemorrhage, Cerebral 3 3
High Blood Pressure/ Hypertension 3 3
Low Blood Pressure/ Hypotension 3 3
Injury 3 3
Patient Problem/Medical Problem 3 3
Numbness 2 2
Loss of consciousness 2 2
Electrolyte Imbalance 2 2
Pneumothorax 2 2
Blurred Vision 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Bone Fracture(s) 2 2
Death 2 2
Ecchymosis 2 2
Fainting 2 2
Cellulitis 2 2
Abrasion 2 2
Abscess 2 2
Arrhythmia 2 2
Renal Impairment 2 2
Missing Value Reason 2 2
Reaction to Medicinal Component of Device 1 1
Stroke/CVA 1 1
Hyperglycemia 1 1
Hemorrhage/Bleeding 1 1
Misdiagnosis 1 1
Tingling 1 1
Skin Discoloration 1 1
Reaction 1 1
Tooth Fracture 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC I May-21-2019
2 Mediana Co., Ltd. II Jul-19-2021
3 Mediana Co., Ltd. II Jun-26-2020
4 Suntech Medical, Inc. II Jun-25-2020
5 Suntech Medical, Inc. II Jan-14-2020
6 Welch Allyn Inc II May-21-2021
7 Welch Allyn Inc II Apr-11-2017
8 Withings Sas II Aug-16-2018
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