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
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT 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	118	118
Suction Problem	111	111
Failure to Power Up	96	99
Smoking	84	84
Suction Failure	81	82
Thermal Decomposition of Device	71	71
Material Frayed	35	35
Incorrect Measurement	35	35
Melted	33	33
Overheating of Device	31	34
Contamination /Decontamination Problem	29	29
Electrical /Electronic Property Problem	20	20
Fluid/Blood Leak	19	19
Device Emits Odor	19	19
Connection Problem	18	18
No Apparent Adverse Event	18	18
Sparking	16	16
Decrease in Suction	15	15
Noise, Audible	15	15
Circuit Failure	13	13
Fire	9	9
Material Deformation	9	9
Insufficient Information	8	8
Vibration	7	7
Material Split, Cut or Torn	6	6
Intermittent Loss of Power	6	6
Appropriate Term/Code Not Available	5	5
Power Problem	5	5
Material Integrity Problem	5	5
Filtration Problem	5	5
Defective Device	5	8
No Display/Image	5	5
Display or Visual Feedback Problem	5	5
Degraded	4	4
Decrease in Pressure	4	4
Use of Device Problem	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Electrical Shorting	4	4
Output Problem	4	4
Failure to Clean Adequately	4	4
Excessive Heating	4	4
Pressure Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Arcing	3	3
Mechanical Problem	3	3
Device Alarm System	3	3
Break	3	3
Material Discolored	2	2
Contamination	2	2
Difficult to Flush	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	734	735
Insufficient Information	34	38
Thrombosis/Thrombus	8	8
Hemorrhage/Bleeding	8	8
Low Oxygen Saturation	8	8
Airway Obstruction	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Patient Involvement	4	4
Discomfort	3	3
Dyspnea	3	3
Laceration(s)	3	3
Aneurysm	2	2
No Consequences Or Impact To Patient	2	2
Unspecified Infection	1	1
Pneumothorax	1	1
Aspiration/Inhalation	1	1
Cardiac Arrest	1	1
Paralysis	1	1
Hypoxia	1	1
Partial thickness (Second Degree) Burn	1	1
Convulsion/Seizure	1	1
Ventilator Dependent	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Laerdal Medical (Suzhou) Co., Ltd.	II	Jan-15-2021
2	Laerdal Medical Corporation	II	Feb-11-2026