TPLC - Total Product Life Cycle

• Device: electrocardiograph
• Regulation Description: Electrocardiograph.
• Product Code: DPS
• Regulation Number: 870.2340
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCURKARDIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALIVECOR, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMCG CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
B-SECUR LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIONET CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
CAF MEDICAL SOLUTIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIACSENSE
	SUBSTANTIALLY EQUIVALENT	2
CARDIOLOGS TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COALA LIFE AB
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EKGENIUS LLC
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
IMEDRIX INC. (FORMERLY PIITECH INC.)
	SUBSTANTIALLY EQUIVALENT	1
INMEDIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
MEDIBLU MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDICALGORITHMICS S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDIZIN SYSTEME BOBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD; MESI, D.O.O.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHYSIQ, INC
	SUBSTANTIALLY EQUIVALENT	1
SCHILLER AG
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRISMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WITHINGS
	SUBSTANTIALLY EQUIVALENT	1
WITHINGS SA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	59	59
2021	24	24
2022	59	59
2023	54	54
2024	63	69
2025	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	85	85
Patient Data Problem	32	32
Intermittent Communication Failure	29	29
Fire	13	13
Insufficient Information	8	8
Detachment of Device or Device Component	8	8
Sparking	7	7
Incorrect, Inadequate or Imprecise Result or Readings	6	12
Smoking	5	5
Therapeutic or Diagnostic Output Failure	5	5
Battery Problem	5	5
Incorrect Interpretation of Signal	4	4
No Display/Image	4	4
Incorrect Measurement	4	10
Data Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Break	3	3
Mechanical Problem	3	3
Display Difficult to Read	3	3
Appropriate Term/Code Not Available	3	3
Computer Operating System Problem	3	3
Loose or Intermittent Connection	2	2
Excessive Heating	2	2
Computer Software Problem	2	2
Product Quality Problem	2	2
Device Emits Odor	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Program or Algorithm Execution Problem	2	2
Operating System Version or Upgrade Problem	2	2
High Readings	2	8
Defective Component	2	2
Application Program Problem	2	2
Output Problem	2	2
Disconnection	2	2
Unable to Obtain Readings	1	1
Patient Device Interaction Problem	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Thermal Decomposition of Device	1	1
Device Difficult to Program or Calibrate	1	1
Material Rupture	1	1
Inability to Auto-Fill	1	1
Device Handling Problem	1	1
Failure to Capture	1	1
Defective Device	1	1
Failure to Transmit Record	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Device Fell	1	1
Explosion	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	164	170
No Patient Involvement	43	43
Insufficient Information	27	27
No Known Impact Or Consequence To Patient	12	12
Superficial (First Degree) Burn	4	4
Electric Shock	3	3
Cardiac Arrest	2	2
Burn(s)	2	2
Burning Sensation	2	2
Myocardial Infarction	2	2
No Consequences Or Impact To Patient	2	2
Eye Pain	2	2
Foreign Body Sensation in Eye	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Shock from Patient Lead(s)	1	1
Abrasion	1	1
Myocarditis	1	1
Ventricular Fibrillation	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Erythema	1	1
Discomfort	1	1
Pain	1	1
Eye Injury	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-14-2025
2	Baxter Healthcare Corporation	II	Nov-07-2024
3	Baxter Healthcare Corporation	II	Jul-10-2024
4	Baxter Healthcare Corporation	II	Jan-10-2024
5	Baxter Healthcare Corporation	II	Jan-24-2023
6	Braemar Manufacturing, LLC	I	Dec-23-2024
7	GE Healthcare, LLC	II	Dec-07-2020
8	Philips North America, LLC	II	Jun-10-2020
9	Schiller, Ag	II	Aug-27-2024
10	WELCH ALLYN, INC/MORTARA	II	Dec-09-2020
11	WELCH ALLYN, INC/MORTARA	II	Apr-29-2020
12	Welch Allyn Inc Mortara	II	Oct-02-2021
13	Welch Allyn Inc Mortara	II	Apr-22-2021
14	Withings	II	Mar-22-2023