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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, portable, aspiration (manual or powered)
Regulation Description Powered suction pump.
Product CodeBTA
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 1
MEDELA HOLDING AG
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 24 24
2017 4 4
2018 17 17
2019 14 14
2020 10 10
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Thermal Decomposition of Device 6 6
Melted 6 6
Nonstandard Device 6 6
Device Emits Odor 5 5
Charging Problem 5 5
Premature Discharge of Battery 4 4
Smoking 4 4
Break 4 4
Device Operates Differently Than Expected 4 4
Gas Leak 4 4
Failure to Charge 3 3
Air Leak 3 3
No Apparent Adverse Event 3 3
Crack 3 3
Device Inoperable 3 3
Electrical Shorting 2 2
Component Falling 2 2
Leak/Splash 2 2
Failure to Run on Battery 2 2
Suction Failure 2 2
Suction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Complete Blockage 1 1
Device Operational Issue 1 1
Improper Flow or Infusion 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Infusion or Flow Problem 1 1
Temperature Problem 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
Fluid Leak 1 1
Fracture 1 1
Mechanical Problem 1 1
No Device Output 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Failure to Pump 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Power Problem 1 1
Misassembled 1 1
Moisture Damage 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Defective Alarm 1 1
Detachment Of Device Component 1 1
Material Distortion 1 1
Loss of Data 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
No Patient Involvement 13 13
No Information 6 6
Hemothorax 5 5
Pneumothorax 4 4
Death 4 4
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Pulmonary Emphysema 2 2
Stroke/CVA 2 2
No Code Available 2 2
Injury 2 2
Increased Respiratory Rate 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Tachycardia 1 1
Fainting 1 1
Cardiopulmonary Arrest 1 1
Dyspnea 1 1
Extubate 1 1
Low Oxygen Saturation 1 1
Embolism/Embolus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medela AG Medical Technology II Apr-27-2021
2 MicroAire Surgical Instruments, LLC II Apr-05-2016
3 Ohio Medical Corporation II Sep-07-2018
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