TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ACARE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DORNOCH MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU EASYCESS MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN BIOMATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate Filtration Process	132	132
Suction Problem	103	103
Failure to Power Up	96	96
Smoking	80	80
Suction Failure	74	74
Thermal Decomposition of Device	72	72
Material Frayed	54	54
Device Emits Odor	48	48
Incorrect Measurement	44	44
Melted	43	43
Filtration Problem	41	41
Contamination /Decontamination Problem	29	29
Overheating of Device	28	28
Fluid/Blood Leak	24	24
Electrical /Electronic Property Problem	22	22
Connection Problem	19	19
No Apparent Adverse Event	19	19
Incorrect, Inadequate or Imprecise Result or Readings	17	17
Circuit Failure	15	15
Sparking	15	15
Decrease in Suction	15	15
Noise, Audible	13	13
Intermittent Loss of Power	8	8
Fire	8	8
Power Problem	8	8
Output Problem	8	8
Material Deformation	8	8
Device Handling Problem	7	7
Misconnection	7	7
Insufficient Information	7	7
Vibration	7	7
Material Split, Cut or Torn	6	6
Electrical Shorting	6	6
Display or Visual Feedback Problem	5	5
Appropriate Term/Code Not Available	5	5
Material Integrity Problem	5	5
No Display/Image	5	5
Failure to Clean Adequately	4	4
Excessive Heating	4	4
Degraded	4	4
Unexpected Shutdown	4	4
Obstruction of Flow	4	4
Device Displays Incorrect Message	4	4
Electrical Power Problem	4	4
Decrease in Pressure	4	4
Leak/Splash	3	3
Defective Device	3	3
Arcing	3	3
Device Alarm System	3	3
Pressure Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	693	693
No Patient Involvement	108	108
No Consequences Or Impact To Patient	82	82
Insufficient Information	33	33
No Known Impact Or Consequence To Patient	14	14
Low Oxygen Saturation	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Laceration(s)	3	3
Aneurysm	2	2
Unspecified Infection	1	1
Pneumothorax	1	1
Aspiration/Inhalation	1	1
Paralysis	1	1
Exposure to Body Fluids	1	1
Fall	1	1
Shock	1	1
Tissue Damage	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