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
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC , INC.
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, 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
STRYKER PHYSIO-CONTROL
	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	83	83
Failure to Capture	21	21
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Adverse Event Without Identified Device or Use Problem	6	6
No Device Output	4	4
Break	4	4
Defective Component	4	4
Use of Device Problem	4	4
Pacing Intermittently	4	4
Material Separation	4	4
Failure to Read Input Signal	3	3
Defective Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Detachment of Device or Device Component	3	3
Capturing Problem	2	2
Physical Resistance/Sticking	2	2
Peeled/Delaminated	2	2
Connection Problem	2	2
Appropriate Term/Code Not Available	2	2
Unable to Obtain Readings	2	2
Device Sensing Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Calibration Problem	2	2
Optical Problem	2	2
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Display or Visual Feedback Problem	1	1
Corroded	1	1
No Pacing	1	1
Overheating of Device	1	1
Human-Device Interface Problem	1	1
Failure to Form Staple	1	1
Loss of Threshold	1	1
Pacing Problem	1	1
Material Protrusion/Extrusion	1	1
Material Deformation	1	1
Gas/Air Leak	1	1
Component Missing	1	1
Device Difficult to Setup or Prepare	1	1
Unintended Ejection	1	1
Material Discolored	1	1
Intermittent Capture	1	1
Air/Gas in Device	1	1
Patient Device Interaction Problem	1	1
Scratched Material	1	1
Failure to Transmit Record	1	1
Unintended Movement	1	1
Poor Quality Image	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	102	102
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
Arrhythmia	1	1
Vascular Dissection	1	1
Burn, Thermal	1	1
Complete Heart Block	1	1
Cardiac Tamponade	1	1
Burn(s)	1	1
Ventricular Fibrillation	1	1
Injury	1	1
Cardiac Perforation	1	1
Discomfort	1	1
No Patient Involvement	1	1
Cardiopulmonary Arrest	1	1
Bradycardia	1	1
Tissue Damage	1	1
Heart Block	1	1