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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
ACARE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DING HWA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DORNOCH MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN BIOMATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 102 102
2018 170 170
2019 132 132
2020 89 89
2021 227 227
2022 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Filtration Process 132 132
Device Emits Odor 80 80
Smoking 78 78
Filtration Problem 60 60
Material Frayed 43 43
Fluid Leak 42 42
Failure to Power Up 42 42
Suction Problem 31 31
Melted 30 30
Incorrect Measurement 26 26
Incorrect, Inadequate or Imprecise Resultor Readings 24 24
Electrical /Electronic Property Problem 24 24
Overheating of Device 23 23
Suction Failure 23 23
Device Handling Problem 22 22
Sparking 20 20
Noise, Audible 17 17
Thermal Decomposition of Device 16 16
Leak/Splash 16 16
Misconnection 16 16
Decrease in Suction 15 15
Connection Problem 15 15
Device Contamination with Body Fluid 11 11
Output Problem 9 9
No Apparent Adverse Event 8 8
Device Operates Differently Than Expected 8 8
Fire 8 8
Vibration 7 7
Aspiration Issue 7 7
Electrical Shorting 6 6
Material Deformation 6 6
Power Problem 6 6
Appropriate Term/Code Not Available 6 6
Unable to Obtain Readings 5 5
Circuit Failure 5 5
Device Damaged Prior to Use 5 5
Pressure Problem 5 5
No Pressure 5 5
Pumping Problem 5 5
Inaccurate Information 5 5
Intermittent Loss of Power 4 4
Complete Blockage 4 4
Excessive Heating 4 4
Material Integrity Problem 4 4
Image Display Error/Artifact 4 4
Improper Device Output 4 4
Device Displays Incorrect Message 4 4
Electrical Power Problem 4 4
Defective Device 4 4
Failure to Pump 4 4
Mechanical Problem 4 4
Break 3 3
Degraded 3 3
Use of Device Problem 3 3
Material Split, Cut or Torn 3 3
Insufficient Information 3 3
Temperature Problem 3 3
Contamination 3 3
Material Discolored 2 2
Device Contamination with Chemical or Other Material 2 2
Improper or Incorrect Procedure or Method 2 2
Arcing 2 2
Reset Problem 2 2
Unexpected Shutdown 2 2
Infusion or Flow Problem 2 2
Protective Measures Problem 2 2
Obstruction of Flow 2 2
Display or Visual Feedback Problem 2 2
Increase in Suction 2 2
Device Alarm System 2 2
Backflow 1 1
Component Falling 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Inappropriate or Unexpected Reset 1 1
Complete Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
No Audible Prompt/Feedback 1 1
Loose or Intermittent Connection 1 1
Overfill 1 1
Pumping Stopped 1 1
No Display/Image 1 1
Charred 1 1
Crack 1 1
No Device Output 1 1
Improper Flow or Infusion 1 1
Device Or Device Fragments Location Unknown 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Failure to Shut Off 1 1
Misassembly by Users 1 1
Bent 1 1
Material Fragmentation 1 1
Off-Label Use 1 1
Failure to Sense 1 1
Loss of Power 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 315 315
No Consequences Or Impact To Patient 246 246
No Patient Involvement 157 157
No Known Impact Or Consequence To Patient 64 64
Insufficient Information 17 17
No Information 3 3
No Code Available 3 3
Death 2 2
Electric Shock 2 2
Aneurysm 2 2
Laceration(s) 2 2
Blood Loss 1 1
Exposure to Body Fluids 1 1
Eye Injury 1 1
Unspecified Infection 1 1
Device Embedded In Tissue or Plaque 1 1
Concussion 1 1
Partial thickness (Second Degree) Burn 1 1
Shock 1 1
Tissue Damage 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Laerdal Medical (Suzhou) Co., Ltd. II Jan-15-2021
2 Laerdal Medical Corporation II Mar-12-2018
3 Laerdal Medical Corporation II Apr-20-2017
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