TPLC - Total Product Life Cycle

• Device: monitor, cardiac (incl. cardiotachometer & rate alarm)
• Product Code: DRT
• Regulation Number: 870.2300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1.  K202138  Cardiac Trigger Monitor
MURATA VIOS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NETEERA TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	2
SLEEPIZ AG
	SUBSTANTIALLY EQUIVALENT	1
XANDAR KARDIAN INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	447	447
2020	50	50
2021	85	85
2022	39	39
2023	69	69
2024	24	24

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unable to Obtain Readings	348	348
Overheating of Device	101	101
Output Problem	95	95
Temperature Problem	89	89
Communication or Transmission Problem	46	46
Incorrect, Inadequate or Imprecise Result or Readings	37	37
Protective Measures Problem	22	22
Power Problem	20	20
No Audible Alarm	18	18
Battery Problem	16	16
Display or Visual Feedback Problem	15	15
Application Program Problem	14	14
Patient Data Problem	12	12
Data Problem	12	12
Complete Loss of Power	11	11
Structural Problem	10	10
Intermittent Communication Failure	9	9
No Device Output	9	9
Device Alarm System	8	8
Failure of Device to Self-Test	6	6
Electrical /Electronic Property Problem	6	6
Signal Artifact/Noise	6	6
Loss of Data	6	6
Image Display Error/Artifact	5	5
Computer Software Problem	5	5
Pacing Problem	4	4
Defibrillation/Stimulation Problem	4	4
Erratic or Intermittent Display	4	4
Unexpected Shutdown	4	4
Patient Device Interaction Problem	4	4
Failure to Read Input Signal	4	4
No Display/Image	4	4
Appropriate Term/Code Not Available	3	3
Incorrect Measurement	3	3
Device Displays Incorrect Message	3	3
Low Readings	3	3
Unintended Electrical Shock	3	3
Intermittent Loss of Power	3	3
Wireless Communication Problem	3	3
Alarm Not Visible	2	2
Failure to Select Signal	2	2
No Audible Prompt/Feedback	2	2
Break	2	2
Failure to Deliver Shock/Stimulation	2	2
Device Sensing Problem	2	2
High Readings	2	2
Contamination /Decontamination Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Erratic Results	1	1
Failure to Charge	1	1
Application Program Problem: Dose Calculation Error	1	1
Premature Discharge of Battery	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Improper or Incorrect Procedure or Method	1	1
Unintended Application Program Shut Down	1	1
Failure to Sense	1	1
Insufficient Information	1	1
Defective Device	1	1
Grounding Malfunction	1	1
Audible Prompt/Feedback Problem	1	1
Electrical Shorting	1	1
Accessory Incompatible	1	1
Application Network Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Failure to Power Up	1	1
Incorrect Interpretation of Signal	1	1
Delayed Alarm	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	262	262
No Patient Involvement	247	247
No Consequences Or Impact To Patient	120	120
No Information	55	55
No Known Impact Or Consequence To Patient	51	51
Death	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cardiac Arrest	3	3
Insufficient Information	2	2
Unspecified Heart Problem	2	2
Unspecified Tissue Injury	2	2
Tachycardia	2	2
Respiratory Distress Syndrome of Newborns	1	1
Skin Discoloration	1	1
Low Oxygen Saturation	1	1
Loss of consciousness	1	1
Low Blood Pressure/ Hypotension	1	1
Electric Shock	1	1
Fever	1	1
Injury	1	1