TPLC - Total Product Life Cycle

show TPLC since

Device	cable, transducer and electrode, patient, (including connector)
Regulation Description	Patient transducer and electrode cable (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
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	1
QT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CORERAY TECHNOLOGY., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER PHYSIO-CONTROL
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
XINKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	92	92
Failure to Capture	16	16
Incorrect, Inadequate or Imprecise Result or Readings	11	11
Adverse Event Without Identified Device or Use Problem	5	5
No Device Output	4	4
Break	4	4
Defective Component	4	4
Defective Device	4	4
Use of Device Problem	4	4
Pacing Intermittently	4	4
Material Separation	4	4
Failure to Read Input Signal	3	3
Detachment of Device or Device Component	3	3
Capturing Problem	2	2
Communication or Transmission Problem	2	2
Physical Resistance/Sticking	2	2
Peeled/Delaminated	2	2
Connection Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unable to Obtain Readings	2	2
Device Sensing Problem	2	2
Calibration Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Display or Visual Feedback Problem	1	1
Corroded	1	1
Overheating of Device	1	1
Human-Device Interface Problem	1	1
Appropriate Term/Code Not Available	1	1
Loss of Threshold	1	1
Pacing Problem	1	1
Material Protrusion/Extrusion	1	1
Optical Problem	1	1
Material Deformation	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
Failure to Transmit Record	1	1
Unintended Movement	1	1
Poor Quality Image	1	1
Crack	1	1
Device Alarm System	1	1
Incomplete or Inadequate Connection	1	1
Mechanical Problem	1	1
Device Slipped	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	114	114
Cardiac Arrest	12	12
No Consequences Or Impact To Patient	12	12
No Known Impact Or Consequence To Patient	9	9
Ventricular Fibrillation	5	5
Insufficient Information	4	4
Heart Block	3	3
Arrhythmia	2	2
Pericardial Effusion	2	2
Asystole	2	2
Failure of Implant	1	1
Vascular Dissection	1	1
Burn, Thermal	1	1
Cardiac Tamponade	1	1
Burn(s)	1	1
Injury	1	1
Cardiac Perforation	1	1
Discomfort	1	1
No Patient Involvement	1	1
Bradycardia	1	1