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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
Regulation Description Noninvasive blood pressure measurement system.
Product CodeDXN
Regulation Number 870.1130
Device Class 2


Premarket Reviews
ManufacturerDecision
A&D COMPANY, LTD
  SUBSTANTIALLY EQUIVALENT 3
A&D COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ADON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AGELESS HEALTH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ALICN MEDICAL (SHENZHEN), INC
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
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
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 5
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 BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 7
HEALTH & LIFE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHCHEK NETWORK, LLC
  SUBSTANTIALLY EQUIVALENT 1
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. GMBH
  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
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
LD TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD
  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 9
PAR MEDIZINTECHNIK GMBH & CO. KG
  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 1
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 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 PUMP MEDICAL SYSTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN URION TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUNTECH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUNTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SUNSPIRI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SUNSPIRIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 2
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

MDR Year MDR Reports MDR Events
2016 53 53
2017 90 90
2018 617 617
2019 96 96
2020 130 130
2021 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 391 391
Incorrect, Inadequate or Imprecise Resultor Readings 293 293
Device Displays Incorrect Message 250 250
Device Operates Differently Than Expected 232 232
Output Problem 220 220
Incorrect Or Inadequate Test Results 177 177
High Test Results 123 123
Fluid Leak 88 88
Incorrect Measurement 63 63
Low Readings 40 40
No Audible Alarm 34 34
Defective Device 26 26
No Device Output 25 25
High Readings 22 22
Therapeutic or Diagnostic Output Failure 18 18
Failure to Pump 17 17
Smoking 15 15
No Audible Prompt/Feedback 15 15
Application Program Freezes, Becomes Nonfunctional 14 14
Overheating of Device 14 14
Break 11 11
Inflation Problem 10 10
Fracture 9 9
Device Inoperable 9 9
Leak/Splash 9 9
Defective Component 8 8
Adverse Event Without Identified Device or Use Problem 8 8
No Display/Image 8 8
Appropriate Term/Code Not Available 8 8
Protective Measures Problem 7 7
Fire 7 7
Computer Operating System Problem 7 7
Mechanical Problem 6 6
Failure to Power Up 6 6
Display or Visual Feedback Problem 6 6
Inaudible or Unclear Audible Prompt/Feedback 6 6
Electrical /Electronic Property Problem 6 6
Device Alarm System 5 5
Battery Problem 5 5
Detachment of Device or Device Component 5 5
Sparking 5 5
Physical Property Issue 5 5
Operating System Becomes Nonfunctional 4 4
Inadequate User Interface 4 4
Pumping Problem 4 4
Insufficient Information 4 4
Malposition of Device 4 4
Low Test Results 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4 4
Unable to Obtain Readings 4 4
Pressure Problem 4 4
Device Fell 4 4
Improper Alarm 4 4
Material Integrity Problem 3 3
Electrical Shorting 3 3
Flare or Flash 3 3
Power Problem 3 3
Decrease in Pressure 3 3
Loose or Intermittent Connection 3 3
Invalid Sensing 3 3
Component Falling 3 3
Infusion or Flow Problem 3 3
Failure to Shut Off 3 3
Device Emits Odor 3 3
False Reading From Device Non-Compliance 2 2
Crack 2 2
Device Slipped 2 2
Device Issue 2 2
Temperature Problem 2 2
Connection Problem 2 2
Device Sensing Problem 2 2
Product Quality Problem 2 2
Device Stops Intermittently 2 2
Material Discolored 2 2
Defective Alarm 2 2
Data Problem 2 2
Improper Device Output 2 2
Issue With Displayed Error Message 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Scratched Material 1 1
No Pressure 1 1
Positioning Problem 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Detachment Of Device Component 1 1
Erratic or Intermittent Display 1 1
Image Display Error/Artifact 1 1
Moisture Damage 1 1
Poor Quality Image 1 1
Energy Output Problem 1 1
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Improper or Incorrect Procedure or Method 1 1
Patient Data Problem 1 1
Noise, Audible 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 759 759
No Clinical Signs, Symptoms or Conditions 128 128
No Consequences Or Impact To Patient 97 97
No Patient Involvement 69 69
Insufficient Information 28 28
No Information 7 7
No Code Available 5 5
Injury 5 5
Pain 5 5
Dizziness 5 5
Bruise/Contusion 4 4
Cardiac Arrest 3 3
Death 3 3
Patient Problem/Medical Problem 3 3
Hemorrhage, Cerebral 3 3
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Skin Discoloration 2 2
Fainting 2 2
Fall 2 2
Loss of consciousness 2 2
Renal Impairment 2 2
Missing Value Reason 2 2
Bone Fracture(s) 2 2
Hemorrhage/Bleeding 2 2
Electrolyte Imbalance 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Pneumothorax 2 2
Blurred Vision 2 2
Tingling 1 1
Complaint, Ill-Defined 1 1
Hemorrhage, Subdural 1 1
Hyperglycemia 1 1
Ecchymosis 1 1
Stroke/CVA 1 1
Test Result 1 1
Reaction 1 1
Tooth Fracture 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Reaction to Medicinal Component of Device 1 1
Hematoma 1 1
Numbness 1 1
Swelling 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A & D Enginering Inc II Oct-09-2016
2 Edwards Lifesciences, LLC I May-21-2019
3 Mediana Co., Ltd. II Jul-19-2021
4 Mediana Co., Ltd. II Jun-26-2020
5 Suntech Medical, Inc. II Jun-25-2020
6 Suntech Medical, Inc. II Jan-14-2020
7 Welch Allyn Inc II May-21-2021
8 Welch Allyn Inc II Apr-11-2017
9 Withings Sas II Aug-16-2018
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