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	2
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	64	70
2025	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	84	84
Patient Data Problem	32	32
Intermittent Communication Failure	29	29
Fire	13	13
Detachment of Device or Device Component	8	8
Sparking	7	7
Insufficient Information	7	7
Incorrect, Inadequate or Imprecise Result or Readings	6	12
Battery Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Smoking	5	5
Incorrect Interpretation of Signal	4	4
Incorrect Measurement	4	10
Data Problem	4	4
No Display/Image	4	4
Computer Operating System Problem	3	3
Break	3	3
Display Difficult to Read	3	3
Appropriate Term/Code Not Available	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Problem	3	3
Application Program Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Excessive Heating	2	2
Output Problem	2	2
Operating System Version or Upgrade Problem	2	2
Disconnection	2	2
Defective Component	2	2
Loose or Intermittent Connection	2	2
Program or Algorithm Execution Problem	2	2
High Readings	2	8
Product Quality Problem	2	2
Device Emits Odor	2	2
Leak/Splash	2	2
Temperature Problem	1	1
Protective Measures Problem	1	1
Material Rupture	1	1
Compatibility Problem	1	1
Signal Artifact/Noise	1	1
Inability to Auto-Fill	1	1
Computer Software Problem	1	1
Device Fell	1	1
Capturing Problem	1	1
Device Handling Problem	1	1
Explosion	1	1
Failure to Capture	1	1
Defective Device	1	1
Failure to Power Up	1	1
Failure to Transmit Record	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	162	168
No Patient Involvement	43	43
Insufficient Information	25	25
No Known Impact Or Consequence To Patient	12	12
Superficial (First Degree) Burn	4	4
Electric Shock	3	3
Myocardial Infarction	2	2
Burning Sensation	2	2
No Consequences Or Impact To Patient	2	2
Eye Pain	2	2
Burn(s)	2	2
Cardiac Arrest	2	2
Pain	1	1
Ventricular Fibrillation	1	1
Discomfort	1	1
Myocarditis	1	1
Shock from Patient Lead(s)	1	1
Abrasion	1	1
Arrhythmia	1	1
Exposure to Body Fluids	1	1
Stroke/CVA	1	1
Chest Pain	1	1
Death	1	1
Erythema	1	1
Eye Injury	1	1
Foreign Body Sensation in Eye	1	1
Hypersensitivity/Allergic reaction	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

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