TPLC - Total Product Life Cycle

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Device	apparatus, suction, ward use, portable, ac-powered
Regulation Description	Powered suction pump.
Product Code	JCX
Regulation Number	878.4780
Device Class	2

Premarket Reviews
Manufacturer	Decision
EXCITUS AS
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU EASYCESS MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate Filtration Process	129	129
Suction Problem	100	100
Failure to Power Up	97	100
Smoking	82	82
Suction Failure	78	78
Thermal Decomposition of Device	72	72
Material Frayed	45	45
Incorrect Measurement	41	41
Melted	39	39
Overheating of Device	35	38
Contamination /Decontamination Problem	29	29
Device Emits Odor	27	27
Electrical /Electronic Property Problem	23	23
Fluid/Blood Leak	22	22
Filtration Problem	19	19
No Apparent Adverse Event	18	18
Connection Problem	18	18
Sparking	16	16
Decrease in Suction	15	15
Circuit Failure	13	13
Noise, Audible	13	13
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Material Deformation	9	9
Fire	9	9
Insufficient Information	8	8
Intermittent Loss of Power	8	8
Vibration	7	7
Power Problem	6	6
Material Split, Cut or Torn	6	6
Output Problem	5	5
Display or Visual Feedback Problem	5	5
Material Integrity Problem	5	5
Appropriate Term/Code Not Available	5	5
No Display/Image	5	5
Electrical Shorting	5	5
Excessive Heating	4	4
Defective Device	4	7
Failure to Clean Adequately	4	4
Degraded	4	4
Decrease in Pressure	4	4
Device Alarm System	3	3
Unexpected Shutdown	3	3
Arcing	3	3
Obstruction of Flow	3	3
Pressure Problem	3	3
Nonstandard Device	2	2
Complete Loss of Power	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Protective Measures Problem	2	2
Loss of Power	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	732	732
No Patient Involvement	47	47
Insufficient Information	35	38
No Consequences Or Impact To Patient	27	27
Low Oxygen Saturation	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Laceration(s)	3	3
No Known Impact Or Consequence To Patient	2	2
Aneurysm	2	2
Unspecified Infection	1	1
Pneumothorax	1	1
Aspiration/Inhalation	1	1
Cardiac Arrest	1	1
Paralysis	1	1
Partial thickness (Second Degree) Burn	1	1
Airway Obstruction	1	1
Ventilator Dependent	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Laerdal Medical (Suzhou) Co., Ltd.	II	Jan-15-2021