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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
Regulation Description Powered suction pump.
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
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Emits Odor 77
Smoking 50
No Pressure 47
Filtration Problem 41
Fluid Leak 37
Suction Problem 36
Device Operates Differently Than Expected 31
Aspiration Issue 29
Device Operational Issue 29
Device Handling Problem 26
Sparking 24
Failure to Pump 18
Misconnection 17
Complete Blockage 17
Leak / Splash 17
Pressure Problem 16
Electrical /Electronic Property Problem 15
Incorrect, Inadequate or Imprecise Result or Readings 15
Failure to Power Up 14
Material Frayed 14
Pumping Problem 12
Noise, Audible 11
Device Contamination with Body Fluid 11
Overheating of Device 10
Incorrect Measurement 9
Device Damaged Prior to Use 8
Output Problem 7
Pumping Stopped 6
Mechanical Problem 6
Melted 6
Inaccurate Information 5
Unable to Obtain Readings 5
Inappropriate Shock 5
Appropriate Term/Code Not Available 5
Electrical Shorting 5
Connection Problem 4
Device Displays Incorrect Message 4
Cut In Material 4
Improper Device Output 4
Power Problem 3
Inadequate Filtration Process 3
Device Stops Intermittently 3
Break 3
Use of Device Problem 3
Contamination During Use 3
Improper or Incorrect Procedure or Method 3
Suction Failure 3
Decrease in Suction 3
Fire 3
Increase in Suction 2
Circuit Failure 2
Decrease in Pressure 2
Temperature Problem 2
Thermal Decomposition of Device 2
Device Alarm System 2
Occlusion Within Device 2
Electrical Power Problem 2
Improper Flow or Infusion 2
Device Contamination with Chemical or Other Material 1
Failure To Run On AC/DC 1
Unexpected Shutdown 1
Detachment Of Device Component 1
Excess Flow or Over-Infusion 1
Defective Device 1
Battery Problem 1
Bent 1
Computer Software Problem 1
Failure to Zero 1
Overfill 1
Material Integrity Problem 1
Device Dislodged or Dislocated 1
Device Fell 1
Power Conditioning Problem 1
Image Display Error / Artifact 1
Pre Or Post-Pumping Problem 1
Failure to Sense 1
Backflow 1
No Device Output 1
Off-Label Use 1
Misassembly by Users 1
Detachment of Device or device Component 1
Adverse Event Without Identified Device or Use Problem 1
Low Readings 1
No Apparent Adverse Event 1
Infusion or Flow Problem 1
Failure to Shut Off 1
Device Inoperable 1
No Audible Prompt / Feedback 1
Failure to Obtain Sample 1
Difficult to Open or Close 1
Air Leak 1
Charred 1
Total Device Problems 779

Recalls
Manufacturer Recall Class Date Posted
1 DeVilbiss Healthcare LLC II Jul-20-2016
2 Gardner Denver Thomas Inc II Jul-20-2015
3 Laerdal Medical Corporation II Mar-12-2018
4 Laerdal Medical Corporation II Apr-20-2017
5 Stryker Instruments Div. of Stryker Corporation II Aug-23-2016
6 Stryker Instruments Div. of Stryker Corporation II Jul-17-2015

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