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
GUANGZHOU EASYCESS MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate Filtration Process	129	129
Failure to Power Up	97	97
Suction Problem	97	97
Smoking	74	74
Suction Failure	74	74
Thermal Decomposition of Device	72	72
Material Frayed	44	44
Incorrect Measurement	41	41
Melted	39	39
Contamination /Decontamination Problem	29	29
Overheating of Device	27	27
Device Emits Odor	25	25
Electrical /Electronic Property Problem	22	22
Fluid/Blood Leak	19	19
Filtration Problem	19	19
Connection Problem	18	18
No Apparent Adverse Event	18	18
Decrease in Suction	15	15
Circuit Failure	13	13
Noise, Audible	12	12
Sparking	12	12
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Intermittent Loss of Power	8	8
Fire	8	8
Material Deformation	8	8
Vibration	7	7
Insufficient Information	7	7
Power Problem	6	6
Material Split, Cut or Torn	6	6
Appropriate Term/Code Not Available	5	5
Output Problem	5	5
Material Integrity Problem	5	5
No Display/Image	5	5
Display or Visual Feedback Problem	5	5
Decrease in Pressure	4	4
Excessive Heating	4	4
Failure to Clean Adequately	4	4
Degraded	4	4
Electrical Shorting	3	3
Obstruction of Flow	3	3
Arcing	3	3
Pressure Problem	3	3
Defective Device	3	3
Unexpected Shutdown	3	3
Device Alarm System	3	3
Unable to Obtain Readings	2	2
Material Discolored	2	2
Contamination	2	2
Unstable	2	2
Fitting Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	703	703
No Patient Involvement	47	47
Insufficient Information	33	33
No Consequences Or Impact To Patient	27	27
Low Oxygen Saturation	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
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