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
BAYLIS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DRÄGERWERK AG & CO. KGAA
	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
SHANGHAI DRAEGER MEDICAL INSTRUMENT CO., 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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	164	165
Blocked Connection	20	20
Incorrect, Inadequate or Imprecise Result or Readings	13	14
Failure to Capture	10	10
Connection Problem	9	9
Loose or Intermittent Connection	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Incorrect Measurement	4	4
Communication or Transmission Problem	3	3
Failure to Sense	3	3
Use of Device Problem	3	3
No Device Output	3	3
Failure to Read Input Signal	2	2
Mechanical Problem	2	2
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Imprecise or Erratic Results	2	2
Calibration Problem	2	2
Device Sensing Problem	2	2
Signal Artifact/Noise	1	1
Failure to Deliver Energy	1	1
Device Alarm System	1	1
Crack	1	2
Poor Quality Image	1	1
Failure to Transmit Record	1	1
Defective Component	1	1
No Audible Alarm	1	1
Patient Device Interaction Problem	1	1
Air/Gas in Device	1	1
Unintended Ejection	1	1
Insufficient Device Problem Information	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Nonstandard Device	1	1
Overheating of Device	1	1
Electrical /Electronic Property Problem	1	1
Device Displays Incorrect Message	1	1
Capturing Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	244	245
Cardiac Arrest	8	9
Insufficient Information	8	8
Asystole	5	5
Ventricular Fibrillation	4	4
Pericardial Effusion	3	3
Bradycardia	3	3
Heart Block	3	3
Arrhythmia	2	2
Air Embolism	1	1
Stroke/CVA	1	1
Failure of Implant	1	1
Vascular Dissection	1	1
Atrial Fibrillation	1	1
Blister	1	1
Localized Skin Lesion	1	1
Burn(s)	1	1
Low Blood Pressure/ Hypotension	1	1
Ischemia Stroke	1	1