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
CRITICARE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FLUKE BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	4
HOANA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
IVY BIOMEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	5
MURATA VIOS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NETEERA TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	2
SLEEPIZ AG
	SUBSTANTIALLY EQUIVALENT	1
VIOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
WR MEDICAL ELECTRONICS CO.
	SUBSTANTIALLY EQUIVALENT	1
XANDAR KARDIAN INC.
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unable to Obtain Readings	514	514
Overheating of Device	179	179
Temperature Problem	151	151
Output Problem	111	111
Device Displays Incorrect Message	82	82
Communication or Transmission Problem	57	57
Incorrect, Inadequate or Imprecise Result or Readings	54	54
Device Operates Differently Than Expected	42	42
No Audible Alarm	26	26
Protective Measures Problem	26	26
Failure of Device to Self-Test	23	23
Power Problem	22	22
Device Alarm System	20	20
Battery Problem	20	20
Device Issue	18	18
Loss of Power	17	17
Misassembly by Users	16	16
Application Program Problem	16	16
Display or Visual Feedback Problem	15	15
Patient Data Problem	15	15
Data Problem	12	12
Device Operational Issue	12	12
Device Inoperable	11	11
Defibrillation/Stimulation Problem	11	11
Complete Loss of Power	11	11
Failure to Read Input Signal	10	10
Structural Problem	10	10
Human Factors Issue	10	10
Intermittent Communication Failure	10	10
Thermal Decomposition of Device	9	9
No Device Output	9	9
Device Sensing Problem	9	9
Pacing Problem	8	8
Electrical /Electronic Property Problem	8	8
No Display/Image	8	8
Image Display Error/Artifact	7	7
Failure to Select Signal	7	7
Signal Artifact/Noise	7	7
Appropriate Term/Code Not Available	6	6
Loss of Data	6	6
Invalid Sensing	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Incorrect Measurement	6	6
Use of Device Problem	5	5
Smoking	5	5
Computer Software Problem	5	5
Unexpected Shutdown	5	5
Patient Device Interaction Problem	4	4
Erratic or Intermittent Display	4	4
Intermittent Loss of Power	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	416	416
No Clinical Signs, Symptoms or Conditions	278	278
No Known Impact Or Consequence To Patient	246	246
No Consequences Or Impact To Patient	176	176
No Information	133	133
Death	35	35
Cardiac Arrest	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Electric Shock	2	2
Injury	2	2
Insufficient Information	2	2
Tachycardia	2	2
Unspecified Tissue Injury	2	2
Unspecified Heart Problem	2	2
Loss of consciousness	2	2
Patient Problem/Medical Problem	1	1
Complaint, Ill-Defined	1	1
Respiratory Distress	1	1
No Code Available	1	1
Head Injury	1	1
Burn, Thermal	1	1
Skin Discoloration	1	1
Burn(s)	1	1
Fever	1	1
Loss Of Pulse	1	1
Anxiety	1	1
Sudden Cardiac Death	1	1
Respiratory Distress Syndrome of Newborns	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ansar Group, Inc. Dba Ansar Medical Technologies, Inc	II	Aug-19-2014
2	Mindray DS USA, Inc. d.b.a. Mindray North America	II	Feb-24-2012