TPLC - Total Product Life Cycle

• Device: system, measurement, blood-pressure, non-invasive
• Product Code: DXN
• Regulation Number: 870.1130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
A&D COMPANY, LTD
	SUBSTANTIALLY EQUIVALENT	2
A&D COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDITECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ALICN MEDICAL (SHENZHEN), INC
	SUBSTANTIALLY EQUIVALENT	1
ALICN MEDICAL SHENZHEN, INC
	SUBSTANTIALLY EQUIVALENT	2
ALICN MEDICAL SHENZHEN,INC
	SUBSTANTIALLY EQUIVALENT	3
ANDON HEALTH CO LTD
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
ATCOR MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BIOLAND TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	2
CARETAKER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CARETAKER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
CNSYSTEMS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
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	2
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	2
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	1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
HEALTH & LIFE CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALTH & LIFE CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HEALTH & LIFE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HETAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
INBODY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	4
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
NANOWEAR INC.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PURSUANT HEALTH
	SUBSTANTIALLY EQUIVALENT	1
PYRAMES INC.
	SUBSTANTIALLY EQUIVALENT	1
QARDIO INC
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
	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	4
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 FINICARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHENZHEN JAMR TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT 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	1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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
VITA-COURSE TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	96	96
2020	130	130
2021	162	162
2022	155	155
2023	165	165
2024	62	62

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	228	228
Incorrect, Inadequate or Imprecise Result or Readings	125	125
Incorrect Measurement	50	50
High Readings	48	48
No Audible Prompt/Feedback	39	39
Insufficient Information	21	21
Therapeutic or Diagnostic Output Failure	18	18
Overheating of Device	18	18
No Audible Alarm	18	18
Smoking	17	17
Defective Device	15	15
Low Readings	14	14
Device Displays Incorrect Message	13	13
Output Problem	12	12
Application Program Freezes, Becomes Nonfunctional	11	11
Failure to Deflate	10	10
Break	10	10
Fracture	10	10
Inflation Problem	9	9
Fire	9	9
Detachment of Device or Device Component	9	9
Inaudible or Unclear Audible Prompt/Feedback	8	8
Defective Component	8	8
High Test Results	8	8
Sparking	7	7
Inadequacy of Device Shape and/or Size	7	7
Failure to Power Up	7	7
Loose or Intermittent Connection	6	6
Display or Visual Feedback Problem	6	6
Computer Operating System Problem	6	6
Patient Device Interaction Problem	6	6
Flare or Flash	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Appropriate Term/Code Not Available	5	5
Device Fell	5	5
Product Quality Problem	5	5
Unable to Obtain Readings	5	5
Patient-Device Incompatibility	5	5
Melted	5	5
No Display/Image	4	4
Device Alarm System	4	4
Deflation Problem	4	4
Inadequate User Interface	4	4
Pressure Problem	4	4
Protective Measures Problem	4	4
No Apparent Adverse Event	3	3
Battery Problem	3	3
Electrical Shorting	3	3
Improper or Incorrect Procedure or Method	3	3
Failure to Shut Off	3	3
Device Sensing Problem	2	2
Electrical Power Problem	2	2
Low Test Results	2	2
No Device Output	2	2
Crack	2	2
Material Discolored	2	2
Display Difficult to Read	2	2
Electrical /Electronic Property Problem	2	2
Increase in Pressure	2	2
Material Integrity Problem	2	2
Air/Gas in Device	1	1
Intermittent Loss of Power	1	1
Audible Prompt/Feedback Problem	1	1
Physical Resistance/Sticking	1	1
Operating System Becomes Nonfunctional	1	1
Data Problem	1	1
Patient Data Problem	1	1
Scratched Material	1	1
Temperature Problem	1	1
Infusion or Flow Problem	1	1
Material Deformation	1	1
Gas/Air Leak	1	1
Material Puncture/Hole	1	1
Decrease in Pressure	1	1
Failure to Run on Battery	1	1
Mechanical Problem	1	1
Moisture Damage	1	1
Poor Quality Image	1	1
Device Emits Odor	1	1
Leak/Splash	1	1
Flushing Problem	1	1
Unintended Power Up	1	1
Defective Alarm	1	1
Circuit Failure	1	1
Computer Software Problem	1	1
Use of Device Problem	1	1
Incorrect Interpretation of Signal	1	1
Application Network Problem	1	1
Device Markings/Labelling Problem	1	1
Failure to Auto Stop	1	1
Calibration Problem	1	1
Charging Problem	1	1
Communication or Transmission Problem	1	1
Activation, Positioning or Separation Problem	1	1
Arcing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	417	417
No Known Impact Or Consequence To Patient	106	106
Insufficient Information	79	79
No Consequences Or Impact To Patient	46	46
No Patient Involvement	36	36
Ecchymosis	31	31
Pain	12	12
Low Blood Pressure/ Hypotension	8	8
High Blood Pressure/ Hypertension	7	7
Dizziness	7	7
Hemorrhage/Bleeding	7	7
Bruise/Contusion	7	7
Fall	6	6
Numbness	5	5
Cardiac Arrest	4	4
Syncope/Fainting	4	4
Swelling/ Edema	3	3
Physical Asymmetry	3	3
Stroke/CVA	3	3
Bone Fracture(s)	3	3
Headache	3	3
Hematoma	3	3
Loss of Range of Motion	3	3
Pneumothorax	2	2
Hypersensitivity/Allergic reaction	2	2
Laceration(s)	2	2
Nerve Damage	2	2
Loss of consciousness	2	2
Electrolyte Imbalance	2	2
Blurred Vision	2	2
Concussion	2	2
Fainting	2	2
Cellulitis	2	2
Abrasion	2	2
Abscess	2	2
Arrhythmia	2	2
Unspecified Heart Problem	2	2
Renal Impairment	2	2
Unspecified Kidney or Urinary Problem	2	2
Easy Bruising	2	2
Myalgia	2	2
Reaction	1	1
Test Result	1	1
No Information	1	1
Reaction to Medicinal Component of Device	1	1
Bradycardia	1	1
Dyspnea	1	1
Hyperglycemia	1	1
Vascular System (Circulation), Impaired	1	1
Blood Loss	1	1
Scar Tissue	1	1
Skin Discoloration	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-10-2024
2	Edwards Lifesciences, LLC	I	May-21-2019
3	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-01-2024
4	Mediana Co., Ltd.	II	Jul-19-2021
5	Mediana Co., Ltd.	II	Jun-26-2020
6	Suntech Medical, Inc.	II	Jun-25-2020
7	Suntech Medical, Inc.	II	Jan-14-2020
8	Welch Allyn Inc	II	May-21-2021