TPLC - Total Product Life Cycle

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Device	monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description	Cardiac monitor (including cardiotachometer and rate alarm).
Product Code	DRT
Regulation Number	870.2300
Device Class	2

Premarket Reviews
Manufacturer	Decision
CIRCADIA TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MURATA VIOS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K232354 Vios Monitoring System(TM) Model 2050; Vios Centra ...
NETEERA TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	2
SLEEPIZ AG
	SUBSTANTIALLY EQUIVALENT	1
XANDAR KARDIAN INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	86	86
Overheating of Device	49	49
Temperature Problem	47	47
Communication or Transmission Problem	38	38
Incorrect, Inadequate or Imprecise Result or Readings	32	32
Power Problem	18	18
Protective Measures Problem	17	17
No Audible Alarm	14	14
Battery Problem	14	14
Display or Visual Feedback Problem	13	13
Patient Data Problem	13	13
Application Program Problem	12	12
Data Problem	11	11
Intermittent Communication Failure	9	9
Complete Loss of Power	9	9
Signal Artifact/Noise	6	6
No Device Output	6	6
Loss of Data	6	6
Unable to Obtain Readings	6	6
Electrical /Electronic Property Problem	5	5
Computer Software Problem	5	5
Image Display Error/Artifact	4	4
Device Alarm System	4	4
Intermittent Loss of Power	4	4
Patient Device Interaction Problem	3	3
Erratic or Intermittent Display	3	3
Pacing Problem	3	3
Appropriate Term/Code Not Available	3	3
No Display/Image	3	3
Unexpected Shutdown	3	3
Unintended Application Program Shut Down	2	2
Failure to Select Signal	2	2
Low Readings	2	2
Device Sensing Problem	2	2
Contamination /Decontamination Problem	2	2
High Readings	2	2
Alarm Not Visible	2	2
Unintended Electrical Shock	2	2
Device Displays Incorrect Message	2	2
Break	2	2
Delayed Alarm	1	1
Application Program Problem: Dose Calculation Error	1	1
Adverse Event Without Identified Device or Use Problem	1	1
No Audible Prompt/Feedback	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Grounding Malfunction	1	1
Application Network Problem	1	1
Erratic Results	1	1
Wireless Communication Problem	1	1
Premature Discharge of Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	247	247
No Consequences Or Impact To Patient	22	22
No Known Impact Or Consequence To Patient	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Patient Involvement	3	3
Insufficient Information	2	2
Tachycardia	2	2
Unspecified Tissue Injury	2	2
Unspecified Heart Problem	2	2
Cardiac Arrest	1	1
Skin Discoloration	1	1
Fever	1	1
Injury	1	1
Partial thickness (Second Degree) Burn	1	1
Respiratory Distress Syndrome of Newborns	1	1
Loss of consciousness	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1