TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
CIRCADIA TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MURATA VIOS, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
Unable to Obtain Readings	351	351
Overheating of Device	101	101
Output Problem	100	100
Temperature Problem	89	89
Communication or Transmission Problem	46	46
Incorrect, Inadequate or Imprecise Result or Readings	39	39
Protective Measures Problem	25	25
No Audible Alarm	22	22
Power Problem	22	22
Battery Problem	17	17
Application Program Problem	15	15
Display or Visual Feedback Problem	15	15
Patient Data Problem	14	14
Data Problem	12	12
Complete Loss of Power	11	11
Structural Problem	10	10
Intermittent Communication Failure	10	10
Device Alarm System	9	9
No Device Output	9	9
Image Display Error/Artifact	6	6
Failure of Device to Self-Test	6	6
Signal Artifact/Noise	6	6
Loss of Data	6	6
Electrical /Electronic Property Problem	6	6
Unexpected Shutdown	5	5
Computer Software Problem	5	5
Patient Device Interaction Problem	4	4
Failure to Read Input Signal	4	4
Intermittent Loss of Power	4	4
Erratic or Intermittent Display	4	4
Pacing Problem	4	4
Defibrillation/Stimulation Problem	4	4
No Display/Image	4	4
Low Readings	3	3
Appropriate Term/Code Not Available	3	3
Device Displays Incorrect Message	3	3
Incorrect Measurement	3	3
Wireless Communication Problem	3	3
Unintended Electrical Shock	3	3
Device Sensing Problem	2	2
Failure to Select Signal	2	2
Failure to Deliver Shock/Stimulation	2	2
No Audible Prompt/Feedback	2	2
Break	2	2
Contamination /Decontamination Problem	2	2
High Readings	2	2
Alarm Not Visible	2	2
Use of Device Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Electrical Shorting	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	276	276
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 Tissue Injury	2	2
Tachycardia	2	2
Unspecified Heart Problem	2	2
Electric Shock	1	1
Skin Discoloration	1	1
Injury	1	1
Fever	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