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 CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
A&D COMPANY, LTD
	SUBSTANTIALLY EQUIVALENT	4
A&D COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	3
ACCUMED HEALTHCARE (SHANGHAI) INC.
	SUBSTANTIALLY EQUIVALENT	2
ACCURATE MEDITECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ADFLOW HEALTH NETWORKS INC
	SUBSTANTIALLY EQUIVALENT	1
ADON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AGELESS HEALTH INDUSTRIAL
	SUBSTANTIALLY EQUIVALENT	1
AGELESS HEALTH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
AGUIFLAI IBERICA S.L.
	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	12
ANDON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
ANDON HEALTH CO.,LTD
	SUBSTANTIALLY EQUIVALENT	44
ANDON MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ATCOR MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOCARE ASIA CORPORATION LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOLAND TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	3
BIOSIGN TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOSPACE CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BMEYE B.V.
	SUBSTANTIALLY EQUIVALENT	1
BRENTWOOD MEDICAL TECHNOLOGY CORP.
	SUBSTANTIALLY EQUIVALENT	1
CALHEALTH INC
	SUBSTANTIALLY EQUIVALENT	1
CARDIOCOM LLC
	SUBSTANTIALLY EQUIVALENT	1
CAREMATIX INC.
	SUBSTANTIALLY EQUIVALENT	1
CARETAKER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CARETAKER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
CITIZEN SYSTEMS JAPAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
CNOGA MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
CNSYSTEMS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
COMPUTERIZED SCREENING, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONMO ELECTRONIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CONTEC MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DATASCOPE CORP., PATIENT MONITORING DIVISION
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFE SCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	6
1.  K122381  NEXFIN MODEL 2
2.  K140312  EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER ...
EDWARDS LIFESCIENCES, LLC.
	SUBSTANTIALLY EQUIVALENT	2
1.  K122381  NEXFIN MODEL 2
2.  K140312  EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER ...
ENGAGEMENTHEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
FAMIDOC TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
FINAPRES MEDICAL SYSTEMS B.V.
	SUBSTANTIALLY EQUIVALENT	1
FINAPRES MEDICAL SYSTEMS BV
	SUBSTANTIALLY EQUIVALENT	2
FORA CARE INC.
	SUBSTANTIALLY EQUIVALENT	2
FUDAKANG INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FUKUDA DENSHI USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUTREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENEXEL MEDICAL INSTRUMENT INC
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL INSTRUMENTATION, LLC
	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	21
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
	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	2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	9
H4D SAS
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
	SUBSTANTIALLY EQUIVALENT	1
HARVARD MEDICAL DEVICES LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEALTH & LIFE CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEALTH & LIFE CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HEALTH & LIFE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	19
HEALTH & LIFE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEALTHCHEK NETWORK, LLC
	SUBSTANTIALLY EQUIVALENT	1
HEALTHSTATS INTERNATIONAL PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
HEALTHSTATS INTERNATIONAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	3
HETAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HIGI SH LLC
	SUBSTANTIALLY EQUIVALENT	2
HONSUN (NANTONG) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HONSUN (NANTONG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HONSUN(NANTONG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HONSUN(NANTONG)CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
HOSMAN INTERNATIONAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
I.E.M. GMBH
	SUBSTANTIALLY EQUIVALENT	3
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
IDT TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
INBODY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	2
INBODY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
JAWON MEDICAL 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
JINXINBAO ELECTRONIC CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JOYTECH HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
JOYTECH HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOYTECH HEALTHCARE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	3
K-JUMP HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LD TECHNOLOGY LLC
	SUBSTANTIALLY EQUIVALENT	3
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LIVEMETRIC (MEDICAL) S.A.
	SUBSTANTIALLY EQUIVALENT	1
LOTUSNINE MEDICAL LIMITED
	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 CORP.
	SUBSTANTIALLY EQUIVALENT	1
MICROLIFE INTELLECTUAL PROPERTY GMBH
	SUBSTANTIALLY EQUIVALENT	26
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND
	SUBSTANTIALLY EQUIVALENT	3
MORTARA INSTRUMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANOWEAR INC.
	SUBSTANTIALLY EQUIVALENT	1
NIHON SEIMITSU SOKKI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
NINGBO DIAIER ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	17
OSTAR MEDITECH CORP.
	SUBSTANTIALLY EQUIVALENT	1
PADTEST, LLC
	SUBSTANTIALLY EQUIVALENT	1
PAR MEDIZINTECHNIK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
PULSECOR LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PURSUANT HEALTH
	SUBSTANTIALLY EQUIVALENT	1
PYRAMES INC.
	SUBSTANTIALLY EQUIVALENT	1
QARDIO 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
ROBERT BOSCH HEALTHCARE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RUDOLF RIESTER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SECA GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SEERS TECHNOLOGY CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
SHANGHAI LITTLE DOCTOR CO. LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
	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 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 JIACOM TECHNOLOGY CO ., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	4
SHENZHEN PANGO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN PANGO ELECTRONIC CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
SHENZHEN URION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN URION TECHNOLOGY 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
SKANRAY TECHNOLOGIES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SKY INNOVATION TECHNOLOGY ( SHANGHAI) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOLOHEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPACELABS HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
STAYHEALTHY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUMMIT DOPPLER SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUNTECH MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SUNTECH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU SUNSPIRI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU SUNSPIRIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
TAIWAN SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TENSYS MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
THERMOR LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRULY INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
TRULY INSTRUMENT LIMITED
	SUBSTANTIALLY EQUIVALENT	2
TRULY INSTRUMENT LTD.
	SUBSTANTIALLY EQUIVALENT	1
TYTAN MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES GTM MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VISIOMED GROUP SA
	SUBSTANTIALLY EQUIVALENT	1
VITA-COURSE TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WATERMARK MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	2
WENZHOU BOKANG INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WISTRON CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
WITHINGS
	SUBSTANTIALLY EQUIVALENT	2
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	3
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZOE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	47	47
2015	63	63
2016	53	53
2017	90	90
2018	617	617
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
Device Operational Issue	391	391
Incorrect, Inadequate or Imprecise Result or Readings	390	390
Device Displays Incorrect Message	265	265
Device Operates Differently Than Expected	246	246
Fluid/Blood Leak	229	229
Output Problem	225	225
Incorrect Or Inadequate Test Results	179	179
High Test Results	125	125
Incorrect Measurement	91	91
High Readings	63	63
Low Readings	53	53
No Audible Alarm	40	40
No Audible Prompt/Feedback	39	39
Defective Device	29	29
No Device Output	27	27
Overheating of Device	25	25
Insufficient Information	25	25
Break	24	24
Smoking	22	22
Inflation Problem	21	21
Therapeutic or Diagnostic Output Failure	18	18
Device Inoperable	17	17
Failure to Pump	17	17
Fire	15	15
Application Program Freezes, Becomes Nonfunctional	14	14
Adverse Event Without Identified Device or Use Problem	12	12
Appropriate Term/Code Not Available	11	11
Detachment of Device or Device Component	11	11
Sparking	10	10
Failure to Deflate	10	10
Defective Component	10	10
Fracture	10	10
Application Interface Becomes Non-Functional Or Program Exits Abnormally	10	10
Display or Visual Feedback Problem	9	9
Leak/Splash	9	9
Loose or Intermittent Connection	9	9
Inaudible or Unclear Audible Prompt/Feedback	9	9
Failure to Power Up	8	8
No Display/Image	8	8
Device Alarm System	8	8
Mechanical Problem	7	7
Electrical /Electronic Property Problem	7	7
Unable to Obtain Readings	7	7
Inadequacy of Device Shape and/or Size	7	7
Protective Measures Problem	7	7
Battery Problem	7	7
Computer Operating System Problem	7	7
Patient-Device Incompatibility	6	6
Flare or Flash	6	6
Operating System Becomes Nonfunctional	6	6
Device Fell	6	6
Patient Device Interaction Problem	6	6
Melted	6	6
Device Emits Odor	5	5
False Reading From Device Non-Compliance	5	5
Deflation Problem	5	5
Component Falling	5	5
Product Quality Problem	5	5
Low Test Results	5	5
Physical Property Issue	5	5
Pressure Problem	5	5
Improper Alarm	5	5
Failure to Shut Off	4	4
Inadequate User Interface	4	4
Infusion or Flow Problem	4	4
Malposition of Device	4	4
Pumping Problem	4	4
Temperature Problem	3	3
Power Problem	3	3
Material Integrity Problem	3	3
No Apparent Adverse Event	3	3
Improper or Incorrect Procedure or Method	3	3
Improper Device Output	3	3
Electrical Shorting	3	3
Invalid Sensing	3	3
Decrease in Pressure	3	3
Increase in Pressure	2	2
Loss of Power	2	2
Device Slipped	2	2
Self-Activation or Keying	2	2
Use of Device Problem	2	2
Device Stops Intermittently	2	2
Device Issue	2	2
Crack	2	2
Material Discolored	2	2
Display Difficult to Read	2	2
Defective Alarm	2	2
Detachment Of Device Component	2	2
Electrical Power Problem	2	2
Gas/Air Leak	2	2
Issue With Displayed Error Message	2	2
Connection Problem	2	2
Device Sensing Problem	2	2
Data Problem	2	2
Patient Data Problem	1	1
Noise, Audible	1	1
Scratched Material	1	1
Naturally Worn	1	1
No Pressure	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	819	819
No Clinical Signs, Symptoms or Conditions	418	418
No Consequences Or Impact To Patient	118	118
Insufficient Information	79	79
No Patient Involvement	69	69
Ecchymosis	32	32
Pain	19	19
No Information	13	13
Bruise/Contusion	12	12
Low Blood Pressure/ Hypotension	9	9
High Blood Pressure/ Hypertension	9	9
Fall	8	8
Hemorrhage/Bleeding	8	8
Dizziness	7	7
Injury	7	7
Cardiac Arrest	5	5
Numbness	5	5
Hematoma	5	5
No Code Available	5	5
Loss of consciousness	4	4
Syncope/Fainting	4	4
Hemorrhage, Subdural	4	4
Nerve Damage	3	3
Headache	3	3
Physical Asymmetry	3	3
Rash	3	3
Swelling/ Edema	3	3
Patient Problem/Medical Problem	3	3
Hypersensitivity/Allergic reaction	3	3
Stroke/CVA	3	3
Bone Fracture(s)	3	3
Death	3	3
Swelling	3	3
Loss of Range of Motion	3	3
Hemorrhage, Cerebral	3	3
Renal Impairment	2	2
Abrasion	2	2
Cellulitis	2	2
Arrhythmia	2	2
Myalgia	2	2
Unspecified Kidney or Urinary Problem	2	2
Electrolyte Imbalance	2	2
Complaint, Ill-Defined	2	2
Seizures	2	2
Laceration(s)	2	2
Skin Discoloration	2	2
Concussion	2	2
Easy Bruising	2	2
Dyspnea	2	2
Unspecified Heart Problem	2	2
Missing Value Reason	2	2
Blurred Vision	2	2
Abscess	2	2
Fainting	2	2
Pneumothorax	2	2
Blood Loss	1	1
Distress	1	1
Discomfort	1	1
Asthma	1	1
Skin Irritation	1	1
Memory Loss/Impairment	1	1
Tingling	1	1
Overdose	1	1
Infarction, Cerebral	1	1
Anaphylactic Shock	1	1
Hyperglycemia	1	1
Myocardial Infarction	1	1
Reaction	1	1
Burning Sensation	1	1
Test Result	1	1
Scar Tissue	1	1
Tooth Fracture	1	1
Syncope	1	1
Vascular System (Circulation), Impaired	1	1
Bradycardia	1	1
Misdiagnosis	1	1
Thrombosis	1	1
Reaction to Medicinal Component of Device	1	1
Physical Entrapment	1	1
Burn(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	A & D Enginering Inc	II	Oct-09-2016
2	Baxter Healthcare Corporation	II	Apr-10-2024
3	Del Mar Reynolds Medical, Ltd.	II	Nov-29-2011
4	Edwards Lifesciences, LLC	I	May-21-2019
5	Edwards Lifesciences, LLC	II	Jun-09-2015
6	FMS, Finapres Medical Systems BV	II	Aug-06-2012
7	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-01-2024
8	Mediana Co., Ltd.	II	Jul-19-2021
9	Mediana Co., Ltd.	II	Jun-26-2020
10	Mindray DS USA, Inc., dba Datascope Patient Monitoring	II	Apr-15-2010
11	Philips Healthcare Inc.	II	Feb-14-2013
12	Philips Healthcare Inc.	II	Aug-30-2012
13	Physio Control, Inc.	II	Sep-18-2009
14	Suntech Medical, Inc.	II	Jun-25-2020
15	Suntech Medical, Inc.	II	Jan-14-2020
16	Welch Allyn Inc	II	May-21-2021
17	Welch Allyn Inc	II	Apr-11-2017
18	Withings Sas	II	Aug-16-2018
19	Zoe Medical Incorporated	II	Aug-03-2010