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
NETEERA TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
SLEEPIZ AG
	SUBSTANTIALLY EQUIVALENT	1
VIOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
XANDAR KARDIAN INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	224	224
2019	447	447
2020	50	50
2021	85	85
2022	39	39
2023	47	47

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unable to Obtain Readings	469	469
Overheating of Device	138	138
Temperature Problem	105	105
Output Problem	85	85
Communication or Transmission Problem	42	42
Incorrect, Inadequate or Imprecise Result or Readings	42	42
Device Displays Incorrect Message	27	27
Protective Measures Problem	18	18
Misassembly by Users	16	16
Device Issue	15	15
No Audible Alarm	15	15
Battery Problem	14	14
Failure of Device to Self-Test	14	14
Power Problem	13	13
Application Program Problem	13	13
Structural Problem	10	10
Human Factors Issue	10	10
Data Problem	10	10
Device Alarm System	10	10
Defibrillation/Stimulation Problem	10	10
Patient Data Problem	9	9
Electrical /Electronic Property Problem	7	7
Display or Visual Feedback Problem	7	7
Complete Loss of Power	7	7
Appropriate Term/Code Not Available	6	6
No Device Output	6	6
Failure to Read Input Signal	6	6
Loss of Data	6	6
Use of Device Problem	5	5
Computer Software Problem	5	5
Intermittent Communication Failure	5	5
Unexpected Shutdown	4	4
Patient Device Interaction Problem	4	4
No Display/Image	4	4
Pacing Problem	4	4
Incorrect Measurement	4	4
Device Sensing Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Device Operates Differently Than Expected	3	3
Device Operational Issue	3	3
Low Readings	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Intermittent Loss of Power	3	3
Unintended Electrical Shock	3	3
Failure to Select Signal	2	2
Incorrect Interpretation of Signal	2	2
Break	2	2
Thermal Decomposition of Device	2	2
Failure to Deliver Shock/Stimulation	2	2
Defective Alarm	2	2
Signal Artifact/Noise	2	2
Insufficient Information	2	2
Wireless Communication Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Electrical Shorting	1	1
Human-Device Interface Problem	1	1
Improper Alarm	1	1
Improper Device Output	1	1
Improper or Incorrect Procedure or Method	1	1
No Audible Prompt/Feedback	1	1
Defective Component	1	1
Invalid Sensing	1	1
Defective Device	1	1
High Readings	1	1
Premature Discharge of Battery	1	1
Alarm Not Visible	1	1
Accessory Incompatible	1	1
Delayed Alarm	1	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1	1
Failure to Discharge	1	1
Application Program Problem: Dose Calculation Error	1	1
Failure to Charge	1	1
Use of Incorrect Control/Treatment Settings	1	1
Failure to Sense	1	1
Output above Specifications	1	1
Grounding Malfunction	1	1
Failure to Power Up	1	1
Unintended Application Program Shut Down	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	344	344
No Clinical Signs, Symptoms or Conditions	216	216
No Consequences Or Impact To Patient	142	142
No Known Impact Or Consequence To Patient	106	106
No Information	94	94
Death	22	22
Cardiac Arrest	4	4
Tachycardia	2	2
Injury	2	2
Loss of consciousness	2	2
Unspecified Heart Problem	2	2
Unspecified Tissue Injury	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Low Oxygen Saturation	1	1
Burn, Thermal	1	1
Electric Shock	1	1
Loss Of Pulse	1	1
No Code Available	1	1
Patient Problem/Medical Problem	1	1
Anxiety	1	1
Fever	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Distress Syndrome of Newborns	1	1
Skin Discoloration	1	1