TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2019	132	132
2020	89	89
2021	227	227
2022	215	215
2023	187	187
2024	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate Filtration Process	132	132
Suction Problem	102	102
Failure to Power Up	93	93
Thermal Decomposition of Device	72	72
Suction Failure	70	70
Smoking	67	67
Material Frayed	52	52
Device Emits Odor	46	46
Melted	42	42
Filtration Problem	41	41
Incorrect Measurement	37	37
Overheating of Device	26	26
Fluid/Blood Leak	23	23
Electrical /Electronic Property Problem	22	22
No Apparent Adverse Event	19	19
Connection Problem	18	18
Incorrect, Inadequate or Imprecise Result or Readings	17	17
Circuit Failure	14	14
Decrease in Suction	13	13
Sparking	12	12
Noise, Audible	12	12
Intermittent Loss of Power	8	8
Output Problem	8	8
Power Problem	8	8
Fire	8	8
Misconnection	7	7
Material Deformation	7	7
Vibration	7	7
Device Handling Problem	7	7
Material Split, Cut or Torn	6	6
Electrical Shorting	6	6
Material Integrity Problem	5	5
No Display/Image	5	5
Display or Visual Feedback Problem	4	4
Degraded	4	4
Decrease in Pressure	4	4
Electrical Power Problem	4	4
Device Displays Incorrect Message	4	4
Obstruction of Flow	4	4
Appropriate Term/Code Not Available	4	4
Failure to Clean Adequately	4	4
Excessive Heating	4	4
Unexpected Shutdown	3	3
Arcing	3	3
Defective Device	3	3
Image Display Error/Artifact	3	3
Leak/Splash	3	3
Nonstandard Device	2	2
Loss of Power	2	2
Material Discolored	2	2
Device Alarm System	2	2
Difficult to Flush	2	2
Device Contamination with Body Fluid	2	2
Increase in Suction	2	2
Unstable	2	2
Crack	2	2
Complete Loss of Power	2	2
Insufficient Information	2	2
Protective Measures Problem	2	2
Reset Problem	2	2
Temperature Problem	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Inaccurate Information	2	2
Misassembled During Installation	1	1
Misassembly by Users	1	1
Pumping Problem	1	1
Activation Failure	1	1
Physical Resistance/Sticking	1	1
Explosion	1	1
Component or Accessory Incompatibility	1	1
Detachment of Device or Device Component	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Pressure Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Gas/Air Leak	1	1
Improper Flow or Infusion	1	1
Inappropriate or Unexpected Reset	1	1
Infusion or Flow Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Problem with Sterilization	1	1
Overfill	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Component Missing	1	1
Break	1	1
Display Difficult to Read	1	1
Complete Blockage	1	1
Computer Software Problem	1	1
Intermittent Continuity	1	1
Corroded	1	1
No Device Output	1	1
Off-Label Use	1	1
Failure to Pump	1	1
Product Quality Problem	1	1
Mechanical Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	624	624
No Patient Involvement	108	108
No Consequences Or Impact To Patient	82	82
Insufficient Information	29	29
No Known Impact Or Consequence To Patient	14	14
No Code Available	3	3
Laceration(s)	3	3
Aneurysm	2	2
Exposure to Body Fluids	1	1
Fall	1	1
Unspecified Infection	1	1
Pneumothorax	1	1
Shock	1	1
Tissue Damage	1	1

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