TPLC - Total Product Life Cycle

• Device: monitor, physiological, patient (without arrhythmia detection or alarms)
• Product Code: MWI
• Regulation Number: 870.2300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCED INSTRUMENTATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AIRSTRIP TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AIRSTRIP TECHNOLOGIES, LP
	SUBSTANTIALLY EQUIVALENT	8
ALERTWATCH LLC
	SUBSTANTIALLY EQUIVALENT	1
AMBIENT CLINICAL ANALYTICS
	SUBSTANTIALLY EQUIVALENT	1
AMC HEALTH
	SUBSTANTIALLY EQUIVALENT	1
AMZETTA TECHNOLOGIES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ANALOG DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ATHENA GTX
	SUBSTANTIALLY EQUIVALENT	4
AXEO MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEDSIDE CLINICAL SYSTEMS INC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BETTERCARE S.L.
	SUBSTANTIALLY EQUIVALENT	1
BIOLOGICAL SIGNAL PROCESSING LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAPSULE SURVEILLANCE TECHNOLOGIES, SAS /CAPSULE TECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAPSULE TECH INC.
	SUBSTANTIALLY EQUIVALENT	1
CAPSULE TECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	2
CAPSULE TECHNOLOGIE SAS
	SUBSTANTIALLY EQUIVALENT	3
CAPSULE TECHNOLOGIE, SAS
	SUBSTANTIALLY EQUIVALENT	1
CAS MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
CASANA CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	4
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
	SUBSTANTIALLY EQUIVALENT	1
DANMEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DECISIO HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DICTUM HEALTH, INC
	SUBSTANTIALLY EQUIVALENT	1
DICTUM HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
DYNOSENSE CORP.
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EKO DEVICES INC
	SUBSTANTIALLY EQUIVALENT	1
EMPATICA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ETIOMETRY, INC.
	SUBSTANTIALLY EQUIVALENT	5
EXCEL MEDICAL ELECTRONICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
FYSICON BV
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
GOLDWAY (US), INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG BIOLIGHT MEDITECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
INFINIUM MEDICAL
	SUBSTANTIALLY EQUIVALENT	6
INNOKAS YHTYMA
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORP.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
IRADIMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
L.D. TECHNOLOGY, LLC
	SUBSTANTIALLY EQUIVALENT	1
LARSEN & TOUBRO LIMITED
	SUBSTANTIALLY EQUIVALENT	4
LD TECHNOLOGY LLC
	SUBSTANTIALLY EQUIVALENT	3
LUTECH INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	12
MCKESSON ISRAEL LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INFORMATICS CORP
	SUBSTANTIALLY EQUIVALENT	1
MEDOPAD INC
	SUBSTANTIALLY EQUIVALENT	1
MEDWAND SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MINDRAY NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	2
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN
	SUBSTANTIALLY EQUIVALENT	2
MULTISENSOR DIAGNOSTICS (DBA AIDAR HEALTH)
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NOBLITT & RUELAND
	SUBSTANTIALLY EQUIVALENT	1
NORAV MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
NUVON, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORDINATRUM SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
PERAHEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
	SUBSTANTIALLY EQUIVALENT	1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	5
REMOTE DIAGNOSTICS TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
RUDOLF RIESTER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI 3F ELECTRONICS CO LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN CREATIVE INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SKANRAY TECHNOLOGIES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SKANRAY TECHNOLOGIES PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
SKANRAY TECHNOLOGIES PVT LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOMANETICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SOTERA WIRELESS, INC
	SUBSTANTIALLY EQUIVALENT	5
SOTERA WIRELESS, INC.
	SUBSTANTIALLY EQUIVALENT	2
STASIS LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TALIS CLINICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
TOSENSE, INC.
	SUBSTANTIALLY EQUIVALENT	2
VIATOM TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VISIOMED TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
VOCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	9
WITT BIOMEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	1
ZOE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	30	30
2015	31	31
2016	51	51
2017	85	85
2018	158	158
2019	169	169
2020	110	110
2021	188	188
2022	168	168
2023	179	179
2024	30	30

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	173	173
High Readings	74	74
Sensing Intermittently	54	54
Inappropriate or Unexpected Reset	51	51
Device Alarm System	47	47
No Audible Alarm	47	47
Unexpected Shutdown	43	43
Incorrect, Inadequate or Imprecise Result or Readings	40	40
Device Operates Differently Than Expected	38	38
Output Problem	33	33
Display or Visual Feedback Problem	33	33
Pitted	29	29
Application Program Freezes, Becomes Nonfunctional	29	29
Unable to Obtain Readings	28	28
No Display/Image	27	27
Insufficient Information	27	27
Sparking	26	26
Low Readings	22	22
Overheating of Device	22	22
Therapeutic or Diagnostic Output Failure	19	19
Device Displays Incorrect Message	18	18
Fire	17	17
Computer Software Problem	17	17
Defective Alarm	17	17
Loss of Power	14	14
Failure to Power Up	14	14
Adverse Event Without Identified Device or Use Problem	14	14
Flare or Flash	14	14
Appropriate Term/Code Not Available	12	12
Loose or Intermittent Connection	12	12
Defibrillation/Stimulation Problem	12	12
Smoking	12	12
Computer Operating System Problem	11	11
No Audible Prompt/Feedback	11	11
Battery Problem	10	10
Device Sensing Problem	10	10
Nonstandard Device	10	10
Operating System Becomes Nonfunctional	9	9
Defective Device	9	9
Application Program Problem	8	8
Device Stops Intermittently	8	8
Melted	7	7
Break	7	7
Electrical /Electronic Property Problem	7	7
Communication or Transmission Problem	7	7
Defective Component	7	7
Electrical Shorting	7	7
Measurement System Incompatibility	6	6
Material Deformation	6	6
Data Problem	6	6
Premature Discharge of Battery	6	6
Failure to Charge	6	6
Detachment Of Device Component	5	5
No Device Output	5	5
Patient Data Problem	5	5
Device Inoperable	5	5
Loss of Data	5	5
Unintended Electrical Shock	5	5
Charging Problem	4	4
Device Fell	4	4
Failure to Read Input Signal	4	4
Inaudible or Unclear Audible Prompt/Feedback	4	4
Improper or Incorrect Procedure or Method	4	4
Protective Measures Problem	4	4
Temperature Problem	4	4
Self-Activation or Keying	4	4
Image Display Error/Artifact	4	4
Component Falling	4	4
Circuit Failure	4	4
Thermal Decomposition of Device	4	4
Failure To Run On AC/DC	4	4
Erratic or Intermittent Display	4	4
Intermittent Continuity	4	4
Application Interface Becomes Non-Functional Or Program Exits Abnormally	4	4
Delayed Alarm	3	3
False Reading From Device Non-Compliance	3	3
Inflation Problem	3	3
Mechanical Problem	3	3
Failure to Analyze Signal	3	3
Power Problem	3	3
Noise, Audible	3	3
Wireless Communication Problem	3	3
Explosion	3	3
Detachment of Device or Device Component	3	3
Device Markings/Labelling Problem	3	3
Arcing	3	3
Patient-Device Incompatibility	2	2
Connection Problem	2	2
Component or Accessory Incompatibility	2	2
Inappropriate Audible Prompt/Feedback	2	2
Invalid Sensing	2	2
Component Missing	2	2
Difficult or Delayed Activation	2	2
Date/Time-Related Software Problem	2	2
Inadequate User Interface	2	2
Failure to Transmit Record	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Leak/Splash	2	2
Image Reversal	2	2
Device Emits Odor	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	500	500
No Consequences Or Impact To Patient	316	316
No Known Impact Or Consequence To Patient	179	179
Insufficient Information	60	60
No Patient Involvement	31	31
Death	22	22
Cardiac Arrest	13	13
No Information	12	12
Electric Shock	9	9
No Code Available	8	8
Burn(s)	8	8
Injury	5	5
Erythema	4	4
Pain	3	3
Burning Sensation	3	3
Partial thickness (Second Degree) Burn	3	3
Burn, Thermal	3	3
Pressure Sores	2	2
Loss Of Pulse	2	2
Superficial (First Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Unspecified Tissue Injury	2	2
Cyanosis	2	2
Tingling	2	2
Skin Discoloration	2	2
Swelling	2	2
Therapeutic Effects, Unexpected	2	2
Tissue Damage	2	2
Ventricular Fibrillation	2	2
Low Blood Pressure/ Hypotension	2	2
Non specific EKG/ECG Changes	2	2
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Arrhythmia	1	1
Cardiopulmonary Arrest	1	1
Ischemia	1	1
Laceration(s)	1	1
Nerve Damage	1	1
Pulmonary Valve Stenosis	1	1
Scar Tissue	1	1
Seizures	1	1
Shock	1	1
Ventricular Tachycardia	1	1
Therapeutic Response, Decreased	1	1
Malaise	1	1
Reaction	1	1
Numbness	1	1
Loss of consciousness	1	1
Sweating	1	1
Low Oxygen Saturation	1	1
Sudden Cardiac Death	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Valvular Stenosis	1	1
Not Applicable	1	1
Asystole	1	1
Unspecified Heart Problem	1	1
Respiratory Arrest	1	1
Skin Disorders	1	1
Patient Problem/Medical Problem	1	1
Vascular System (Circulation), Impaired	1	1
Discomfort	1	1
Complaint, Ill-Defined	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Sep-12-2023
2	Capsule Tech Inc.	II	Sep-13-2012
3	Capsule Tech Inc.	II	Jun-01-2011
4	INNOKAS MEDICAL OY	II	Aug-19-2016
5	INNOKAS MEDICAL OY	II	Jan-28-2015
6	Infinium Medical, Inc	II	Jul-02-2019
7	Innokas Medical Oy	II	Nov-11-2015
8	Invivo Corporation	II	Sep-18-2018
9	Invivo Corporation	II	Jun-07-2018
10	Invivo Corporation	II	May-14-2018
11	Invivo Corporation	II	Dec-19-2017
12	Invivo Corporation	II	Nov-09-2017
13	Invivo Corporation	II	Sep-21-2016
14	Invivo Corporation	II	Sep-08-2016
15	Invivo Corporation	II	Jan-13-2015
16	Invivo Corporation	II	Oct-15-2014
17	Invivo Corporation	II	Oct-01-2014
18	Invivo Corporation	II	Aug-19-2014
19	Invivo Corporation	II	Feb-26-2014
20	Invivo Corporation	II	Feb-14-2014
21	Invivo Corporation	II	Dec-04-2012
22	Invivo Corporation	II	Oct-27-2011
23	Invivo Corporation	II	Oct-25-2011
24	Invivo Corporation	II	Feb-06-2009
25	Mckesson Information Solutions LLC	II	Oct-20-2014
26	Mckesson Information Solutions LLC	II	Oct-08-2014
27	Medrad Inc	II	Jun-25-2013
28	Medrad Mr Inc	II	Jan-23-2014
29	Mindray DS USA, Inc. d.b.a. Mindray North America	II	Jan-27-2013
30	Mindray DS USA, Inc. dba Mindray North America	II	Oct-29-2019
31	Nellcor Puritan Bennett Inc. (dba Covidien LP)	II	Aug-14-2014
32	Philips Electronics North America Corporation	II	Jul-27-2015
33	Philips Healthcare Inc.	II	Apr-08-2010
34	Philips North America, LLC	II	Aug-14-2020
35	Philips North America, LLC	II	Jun-02-2020
36	Philips North America, LLC	II	Mar-31-2020
37	Philips North America Llc	II	Oct-04-2022
38	Philips North America Llc	II	May-06-2022
39	Philips North America Llc	II	Apr-29-2021
40	Remote Diagnostic Technologies Ltd.	II	May-11-2011
41	Sotera Wireless, Inc.	II	Jul-29-2013
42	Viterion TeleHealthcare Llc	II	Feb-14-2013
43	Viterion TeleHealthcare Llc	II	Feb-15-2012
44	Welch Allyn Protocol, Inc	II	Jan-07-2014
45	Welch Allyn Protocol, Inc	II	Jul-30-2009