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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
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 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Filtration Process 132 132
Suction Problem 102 102
Failure to Power Up 95 95
Suction Failure 74 74
Smoking 73 73
Thermal Decomposition of Device 72 72
Material Frayed 54 54
Device Emits Odor 47 47
Incorrect Measurement 44 44
Melted 42 42
Filtration Problem 41 41
Overheating of Device 27 27
Fluid/Blood Leak 24 24
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 15 15
Decrease in Suction 14 14
Noise, Audible 13 13
Sparking 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
Vibration 7 7
Insufficient Information 7 7
Material Split, Cut or Torn 6 6
Electrical Shorting 6 6
Display or Visual Feedback Problem 5 5
Material Integrity Problem 5 5
No Display/Image 5 5
Appropriate Term/Code Not Available 4 4
Excessive Heating 4 4
Unexpected Shutdown 4 4
Failure to Clean Adequately 4 4
Decrease in Pressure 4 4
Electrical Power Problem 4 4
Degraded 4 4
Device Displays Incorrect Message 4 4
Obstruction of Flow 4 4
Device Alarm System 3 3
Image Display Error/Artifact 3 3
Pressure Problem 3 3
Arcing 3 3
Defective Device 3 3
Leak/Splash 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 654 654
No Patient Involvement 108 108
No Consequences Or Impact To Patient 82 82
Insufficient Information 31 31
No Known Impact Or Consequence To Patient 14 14
Low Oxygen Saturation 8 8
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
Airway Obstruction 1 1

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