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	2
VIOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
XANDAR KARDIAN INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	159	159
2018	224	224
2019	447	447
2020	49	49
2021	85	85
2022	18	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unable to Obtain Readings	508	508
Overheating of Device	145	145
Temperature Problem	129	129
Output Problem	64	64
Device Displays Incorrect Message	64	64
Communication or Transmission Problem	31	31
Incorrect, Inadequate or Imprecise Resultor Readings	31	31
Failure of Device to Self-Test	20	20
Misassembly by Users	16	16
Device Issue	15	15
Application Program Problem	12	12
Battery Problem	11	11
Defibrillation/Stimulation Problem	11	11
Structural Problem	10	10
Human Factors Issue	10	10
Device Operates Differently Than Expected	10	10
Failure to Read Input Signal	8	8
Pacing Problem	7	7
Device Alarm System	7	7
Protective Measures Problem	7	7
Appropriate Term/Code Not Available	6	6
Data Problem	6	6
No Audible Alarm	6	6
Thermal Decomposition of Device	6	6
Incorrect Measurement	6	6
Device Operational Issue	6	6
Loss of Data	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Use of Device Problem	5	5
Invalid Sensing	5	5
Computer Software Problem	5	5
Electrical /Electronic Property Problem	5	5
No Display/Image	4	4
No Device Output	4	4
Smoking	4	4
Device Sensing Problem	4	4
Power Problem	3	3
Failure to Select Signal	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Failure to Analyze Signal	3	3
Incorrect Interpretation of Signal	3	3
Display or Visual Feedback Problem	3	3
Patient Data Problem	3	3
Unintended Electrical Shock	3	3
Unexpected Shutdown	2	2
Insufficient Information	2	2
Patient Device Interaction Problem	2	2
Intermittent Loss of Power	2	2
Failure to Deliver Shock/Stimulation	2	2
Defective Alarm	2	2
Failure to Sense	2	2
Device Emits Odor	2	2
Failure to Power Up	2	2
Low Readings	2	2
Improper Alarm	2	2
Improper Device Output	2	2
Therapeutic or Diagnostic Output Failure	1	1
Electrical Shorting	1	1
Human-Device Interface Problem	1	1
Incorrect Or Inadequate Test Results	1	1
Defective Device	1	1
Device Inoperable	1	1
Improper or Incorrect Procedure or Method	1	1
Electro-Static Discharge	1	1
No Audible Prompt/Feedback	1	1
Defective Component	1	1
Output above Specifications	1	1
Melted	1	1
Accessory Incompatible	1	1
Loss of Power	1	1
Failure to Transmit Record	1	1
Alarm Not Visible	1	1
Signal Artifact/Noise	1	1
Use of Incorrect Control Settings	1	1
Failure to Charge	1	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1	1
Failure to Discharge	1	1
Material Discolored	1	1
Grounding Malfunction	1	1
Image Display Error/Artifact	1	1
Wireless Communication Problem	1	1
Unintended Application Program Shut Down	1	1
Intermittent Communication Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	399	399
No Consequences Or Impact To Patient	163	163
No Known Impact Or Consequence To Patient	159	159
No Information	127	127
No Clinical Signs, Symptoms or Conditions	127	127
Death	31	31
Cardiac Arrest	5	5
Unspecified Heart Problem	2	2
Unspecified Tissue Injury	2	2
Injury	2	2
Loss of consciousness	1	1
Sudden Cardiac Death	1	1
Burn, Thermal	1	1
Electric Shock	1	1
Loss Of Pulse	1	1
Skin Discoloration	1	1
Tachycardia	1	1
Anxiety	1	1
Insufficient Information	1	1
No Code Available	1	1
Patient Problem/Medical Problem	1	1