TPLC - Total Product Life Cycle

show TPLC since

Device	cable, transducer and electrode, patient, (including connector)
Product Code	DSA
Regulation Number	870.2900
Device Class	2

Premarket Reviews
Manufacturer	Decision
ATRILITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AUTHENTIC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENERGETIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOGG SYSTEM COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC , INC.
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
QT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN CORERAY TECHNOLOGY., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
XINKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	68	68
Failure to Capture	21	21
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Adverse Event Without Identified Device or Use Problem	6	6
Defective Component	4	4
Material Separation	4	4
Break	4	4
Pacing Intermittently	4	4
Failure to Read Input Signal	3	3
Use of Device Problem	3	3
Detachment of Device or Device Component	3	3
Therapeutic or Diagnostic Output Failure	3	3
Physical Resistance/Sticking	2	2
Connection Problem	2	2
Device Sensing Problem	2	2
Defective Device	2	2
Calibration Problem	2	2
Capturing Problem	2	2
Unable to Obtain Readings	2	2
Inadequacy of Device Shape and/or Size	2	2
Peeled/Delaminated	2	2
No Device Output	2	2
Overheating of Device	1	1
Pacing Problem	1	1
Device Difficult to Setup or Prepare	1	1
Intermittent Capture	1	1
Device Alarm System	1	1
Loss of or Failure to Bond	1	1
Corroded	1	1
Crack	1	1
Material Discolored	1	1
Disconnection	1	1
Display or Visual Feedback Problem	1	1
Unintended Ejection	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Poor Quality Image	1	1
Device Slipped	1	1
Loss of Threshold	1	1
Failure to Transmit Record	1	1
Improper or Incorrect Procedure or Method	1	1
Communication or Transmission Problem	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Incomplete or Inadequate Connection	1	1
Optical Problem	1	1
Scratched Material	1	1
Unintended Movement	1	1
Appropriate Term/Code Not Available	1	1
No Pacing	1	1
Patient Device Interaction Problem	1	1
Component Missing	1	1
Failure to Form Staple	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	83	83
No Known Impact Or Consequence To Patient	17	17
No Consequences Or Impact To Patient	12	12
Cardiac Arrest	9	9
Insufficient Information	4	4
Pericardial Effusion	2	2
Asystole	2	2
Tissue Damage	1	1
Arrhythmia	1	1
Bradycardia	1	1
Heart Block	1	1
Complete Heart Block	1	1
Burn(s)	1	1
Vascular Dissection	1	1
No Patient Involvement	1	1
Cardiac Perforation	1	1
Cardiac Tamponade	1	1
Cardiopulmonary Arrest	1	1
Discomfort	1	1
Burn, Thermal	1	1
Ventricular Fibrillation	1	1
Injury	1	1