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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 1
AGELESS HEALTH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL (SHENZHEN), INC
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 3
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARETAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 4
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FINAPRES MEDICAL SYSTEMS B.V.
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GMC INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
HONSUN(NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
INBODY CO, LTD.
  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
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 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 1
MEDITECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CARE MANAGEMENT SERVICES
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 9
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 2
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 1
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 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
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
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 617 617
2019 96 96
2020 130 130
2021 162 162
2022 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 391 391
Incorrect, Inadequate or Imprecise Result or Readings 286 286
Device Displays Incorrect Message 239 239
Output Problem 223 223
Device Operates Differently Than Expected 200 200
Fluid/Blood Leak 194 194
Incorrect Or Inadequate Test Results 170 170
High Test Results 121 121
Incorrect Measurement 54 54
Low Readings 42 42
No Audible Prompt/Feedback 31 31
High Readings 26 26
Defective Device 25 25
No Device Output 25 25
No Audible Alarm 25 25
Overheating of Device 20 20
Therapeutic or Diagnostic Output Failure 18 18
Failure to Pump 17 17
Smoking 14 14
Application Program Freezes, Becomes Nonfunctional 14 14
Fire 12 12
Inflation Problem 11 11
Fracture 10 10
Break 10 10
Inaudible or Unclear Audible Prompt/Feedback 9 9
Insufficient Information 9 9
Appropriate Term/Code Not Available 9 9
Detachment of Device or Device Component 8 8
No Display/Image 8 8
Display or Visual Feedback Problem 8 8
Loose or Intermittent Connection 7 7
Failure to Power Up 7 7
Mechanical Problem 7 7
Defective Component 7 7
Protective Measures Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Computer Operating System Problem 6 6
Electrical /Electronic Property Problem 6 6
Leak/Splash 6 6
Battery Problem 5 5
Physical Property Issue 5 5
Flare or Flash 5 5
Device Fell 5 5
Pumping Problem 4 4
Pressure Problem 4 4
Inadequate User Interface 4 4
Improper Alarm 4 4
Malposition of Device 4 4
Low Test Results 4 4
Unable to Obtain Readings 4 4
Product Quality Problem 3 3
Decrease in Pressure 3 3
Device Alarm System 3 3
Sparking 3 3
Power Problem 3 3
Infusion or Flow Problem 3 3
Electrical Shorting 3 3
Failure to Shut Off 3 3
Failure to Deflate 3 3
Operating System Becomes Nonfunctional 2 2
Gas/Air Leak 2 2
Issue With Displayed Error Message 2 2
Improper Device Output 2 2
Electrical Power Problem 2 2
Material Integrity Problem 2 2
Device Sensing Problem 2 2
Device Inoperable 2 2
Device Issue 2 2
Crack 2 2
Material Discolored 2 2
Display Difficult to Read 2 2
Erratic or Intermittent Display 1 1
Image Display Error/Artifact 1 1
Deflation Problem 1 1
Unintended Power Up 1 1
Defective Alarm 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Melted 1 1
Moisture Damage 1 1
Poor Quality Image 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Failure to Run on Battery 1 1
Loss of Power 1 1
Arcing 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Device Stops Intermittently 1 1
Device Slipped 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Patient-Device Incompatibility 1 1
Application Network Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 678 678
No Clinical Signs, Symptoms or Conditions 298 298
No Consequences Or Impact To Patient 65 65
No Patient Involvement 57 57
Insufficient Information 36 36
Pain 7 7
Dizziness 5 5
Cardiac Arrest 5 5
Low Blood Pressure/ Hypotension 5 5
No Information 5 5
No Code Available 4 4
Syncope/Fainting 4 4
High Blood Pressure/ Hypertension 4 4
Fall 4 4
Hematoma 3 3
Ecchymosis 3 3
Loss of Range of Motion 3 3
Patient Problem/Medical Problem 3 3
Injury 3 3
Physical Asymmetry 3 3
Swelling/ Edema 3 3
Blurred Vision 2 2
Renal Impairment 2 2
Missing Value Reason 2 2
Numbness 2 2
Loss of consciousness 2 2
Pneumothorax 2 2
Electrolyte Imbalance 2 2
Myalgia 2 2
Fainting 2 2
Cellulitis 2 2
Abrasion 2 2
Abscess 2 2
Arrhythmia 2 2
Bone Fracture(s) 2 2
Death 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Skin Discoloration 1 1
Tooth Fracture 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Reaction 1 1
Test Result 1 1
Reaction to Medicinal Component of Device 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 Withings Sas II Aug-16-2018
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