TPLC - Total Product Life Cycle

show TPLC since

Device	transducer, blood-pressure, extravascular
Product Code	DRS
Regulation Number	870.2850
Device Class	2

Premarket Reviews
Manufacturer	Decision
B. BRAUN MELSUNGEN AG
	SUBSTANTIALLY EQUIVALENT	1
BIOMETRIX LTD.
	SUBSTANTIALLY EQUIVALENT	1
CENTURION MEDICAL PRODUCTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL A.C.A.L
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
REAVILLMED
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	137	137
Fluid/Blood Leak	122	122
Disconnection	110	110
Leak/Splash	110	110
Break	72	72
Incorrect, Inadequate or Imprecise Result or Readings	69	69
Detachment Of Device Component	49	49
Separation Failure	29	29
Detachment of Device or Device Component	23	23
Separation Problem	23	23
Crack	14	14
Air Leak	14	14
Incorrect Measurement	13	13
Pressure Problem	13	13
Unable to Obtain Readings	13	13
Inaccurate Information	12	12
Device Contamination with Chemical or Other Material	12	12
Air/Gas in Device	11	11
No Flow	10	10
Connection Problem	10	10
High Readings	10	10
Device Operates Differently Than Expected	9	9
Output Problem	8	8
Failure to Reset	8	8
Particulates	8	8
Device Issue	7	7
Infusion or Flow Problem	7	7
Loss of or Failure to Bond	7	7
Mechanical Problem	6	6
Display or Visual Feedback Problem	6	6
Loose or Intermittent Connection	6	6
Material Split, Cut or Torn	6	6
Backflow	6	6
Device Sensing Problem	5	5
Failure to Zero	5	5
Device Markings/Labelling Problem	5	5
Reflux within Device	5	5
Device Displays Incorrect Message	4	4
Material Integrity Problem	4	4
Difficult to Insert	4	4
Device Inoperable	3	3
Contamination	3	3
Obstruction of Flow	3	3
Improper Flow or Infusion	3	3
No Device Output	3	3
Defective Device	3	3
Failure to Calibrate	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Inappropriate Waveform	3	3
Difficult to Flush	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	439	439
No Consequences Or Impact To Patient	300	300
No Known Impact Or Consequence To Patient	95	95
Blood Loss	46	47
No Patient Involvement	30	30
Insufficient Information	23	23
Hemorrhage/Bleeding	21	21
No Information	14	14
Death	6	6
Not Applicable	3	3
Exposure to Body Fluids	3	3
Low Blood Pressure/ Hypotension	3	3
Cardiac Arrest	2	2
Discomfort	2	2
Air Embolism	1	1
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Stroke/CVA	1	1
Pneumothorax	1	1
Complaint, Ill-Defined	1	1
Respiratory Distress	1	1
Anemia	1	1
Edema	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Burn(s)	1	1
Thrombosis	1	1
Extravasation	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Atrial Flutter	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1