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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 102 102

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
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