TPLC - Total Product Life Cycle

• Device: detector and alarm, arrhythmia
• Regulation Description: Arrhythmia detector and alarm (including ST-segment measurement and alarm).
• Product Code: DSI
• Regulation Number: 870.1025
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INFOBIONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
IRHYTHM TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMARTCARDIA SA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	3091	3092
2022	1638	1646
2023	1615	1619
2024	1320	1323
2025	727	727
2026	104	104

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	2264	2267
Under-Sensing	1478	1478
Over-Sensing	1006	1006
No Audible Prompt/Feedback	812	813
Communication or Transmission Problem	594	596
Reset Problem	424	424
Signal Artifact/Noise	416	416
Device Sensing Problem	317	317
Adverse Event Without Identified Device or Use Problem	303	303
Migration or Expulsion of Device	238	238
Unable to Obtain Readings	179	179
Defective Alarm	167	170
Electromagnetic Interference	157	157
Failure to Interrogate	151	152
Device Alarm System	118	124
Battery Problem	105	105
Appropriate Term/Code Not Available	105	105
Inappropriate or Unexpected Reset	96	96
Overheating of Device	82	82
Failure to Transmit Record	59	59
Decreased Sensitivity	51	51
Melted	46	47
Data Problem	44	44
Audible Prompt/Feedback Problem	42	42
Output Problem	41	42
Premature Discharge of Battery	39	40
Insufficient Information	39	40
Patient Device Interaction Problem	39	41
Device Difficult to Program or Calibrate	37	37
Excessive Heating	33	33
Biocompatibility	32	32
Low Audible Alarm	31	31
Alarm Not Visible	30	30
Incorrect Measurement	29	29
Patient-Device Incompatibility	25	25
Display or Visual Feedback Problem	25	25
Use of Device Problem	25	25
Temperature Problem	24	25
Device-Device Incompatibility	23	23
No Device Output	22	22
Incorrect, Inadequate or Imprecise Result or Readings	22	23
Delayed Alarm	20	20
Inaudible or Unclear Audible Prompt/Feedback	19	19
Smoking	19	19
Human-Device Interface Problem	17	17
Computer Software Problem	16	16
Fire	15	15
Unintended Electrical Shock	14	14
Wireless Communication Problem	14	14
Electrical /Electronic Property Problem	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7554	7565
Insufficient Information	195	196
Unspecified Infection	140	140
Pain	99	99
Erosion	74	74
No Patient Involvement	67	67
Skin Inflammation/ Irritation	60	60
Unspecified Heart Problem	54	55
Cardiac Arrest	50	50
Hypersensitivity/Allergic reaction	35	35
Erythema	30	30
Blister	26	26
Discomfort	25	25
Superficial (First Degree) Burn	18	19
Rash	17	17
Swelling/ Edema	17	17
Asystole	16	16
Itching Sensation	15	15
Hemorrhage/Bleeding	14	14
Low Oxygen Saturation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Arrhythmia	13	13
Hypoxia	13	13
Bradycardia	13	13
Impaired Healing	12	12
Burning Sensation	11	11
Tachycardia	11	11
Electric Shock	9	9
Burn(s)	9	9
Purulent Discharge	8	8
Skin Burning Sensation	8	8
Ventricular Fibrillation	8	8
No Consequences Or Impact To Patient	7	7
Twiddlers Syndrome	7	7
Skin Tears	7	7
Bacterial Infection	6	6
Diaphoresis	6	6
Atrial Fibrillation	6	6
Localized Skin Lesion	6	6
Numbness	6	6
Wound Dehiscence	6	6
Chest Pain	6	6
Skin Erosion	6	6
Hematoma	5	5
Bruise/Contusion	5	6
Local Reaction	5	5
Syncope/Fainting	5	5
Failure of Implant	4	4
Headache	4	4
Unspecified Tissue Injury	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Medical Systems Information Technologies Inc	II	Jun-10-2025
2	Philips North America	II	Oct-08-2024
3	Philips North America	II	Oct-01-2024
4	Philips North America Llc	II	Dec-02-2025
5	Philips North America Llc	II	May-21-2021
6	Spacelabs Healthcare, Inc.	II	Apr-07-2026
7	Spacelabs Healthcare, Inc.	II	May-03-2023
8	iRhythm Technologies, Inc.	II	Nov-04-2022