TPLC - Total Product Life Cycle

• Device: 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
GENETESIS INC.
	SUBSTANTIALLY EQUIVALENT	1
IMEDRIX INC. (FORMERLY PIITECH 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
PHYSIQ, INC
	SUBSTANTIALLY EQUIVALENT	2
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
ZOLL MANUFACTURING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	27	27
2020	59	59
2021	24	24
2022	59	59
2023	54	54
2024	47	53

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	78	78
Intermittent Communication Failure	29	29
Patient Data Problem	29	29
Fire	15	15
Unable to Obtain Readings	11	11
Incorrect, Inadequate or Imprecise Result or Readings	9	15
Sparking	7	7
Insufficient Information	7	7
Therapeutic or Diagnostic Output Failure	6	6
Smoking	6	6
No Display/Image	5	5
Incorrect Measurement	5	11
Battery Problem	5	5
Incorrect Interpretation of Signal	4	4
Computer Operating System Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Output Problem	3	3
Mechanical Problem	3	3
Break	3	3
Connection Problem	3	3
Display Difficult to Read	3	3
Application Program Problem	3	3
Appropriate Term/Code Not Available	3	3
Detachment of Device or Device Component	3	3
Data Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Operating System Version or Upgrade Problem	2	2
High Readings	2	8
Loose or Intermittent Connection	2	2
Excessive Heating	2	2
Device Emits Odor	2	2
Product Quality Problem	2	2
Use of Device Problem	2	2
Program or Algorithm Execution Problem	2	2
Defective Component	2	2
Image Display Error/Artifact	2	2
Disconnection	2	2
Leak/Splash	2	2
Thermal Decomposition of Device	1	1
Material Rupture	1	1
Device Handling Problem	1	1
Failure to Power Up	1	1
Device Difficult to Program or Calibrate	1	1
Explosion	1	1
Defective Device	1	1
Device Fell	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Failure to Capture	1	1
Computer Software Problem	1	1
Device Alarm System	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	146	152
No Patient Involvement	50	50
Insufficient Information	25	25
No Known Impact Or Consequence To Patient	23	23
No Consequences Or Impact To Patient	6	6
Superficial (First Degree) Burn	4	4
Death	4	4
Myocardial Infarction	4	4
Electric Shock	3	3
Cardiac Arrest	2	2
Burn(s)	2	2
Burning Sensation	2	2
Eye Pain	2	2
Foreign Body Sensation in Eye	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Stroke/CVA	1	1
Hypersensitivity/Allergic reaction	1	1
Shock from Patient Lead(s)	1	1
Ischemia	1	1
Abrasion	1	1
Complete Heart Block	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	Jul-10-2024
2	Baxter Healthcare Corporation	II	Jan-10-2024
3	Baxter Healthcare Corporation	II	Jan-24-2023
4	GE Healthcare, LLC	II	Dec-07-2020
5	Philips North America, LLC	II	Jun-10-2020
6	Philips North America, LLC	II	Feb-21-2019
7	Schiller, Ag	II	Aug-27-2024
8	WELCH ALLYN, INC/MORTARA	II	Dec-09-2020
9	WELCH ALLYN, INC/MORTARA	II	Apr-29-2020
10	Welch Allyn Inc Mortara	II	Oct-02-2021
11	Welch Allyn Inc Mortara	II	Apr-22-2021
12	Withings	II	Mar-22-2023