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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
ANOXIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATMOS MEDIZINTECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CRO, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUANSHI YIYINGMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRW MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GEON CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GI SUPPLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DESIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN DONGJIANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KINGBOOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN XINLIANFENG TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SOMAVAC MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 9 9
2022 7 7
2023 8 8
2024 13 13
2025 13 13
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 8 8
Battery Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Suction Failure 4 4
Decrease in Suction 4 4
Suction Problem 3 3
Decrease in Pressure 2 2
Failure to Run on Battery 2 2
Mechanical Jam 2 2
Infusion or Flow Problem 2 2
Display or Visual Feedback Problem 1 1
Pumping Stopped 1 1
Power Problem 1 1
Unclear Information 1 1
Fluid/Blood Leak 1 1
Device Damaged Prior to Use 1 1
Electrical /Electronic Property Problem 1 1
Smoking 1 1
Fracture 1 1
Failure to Pump 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
Insufficient Information 13 13
Pneumothorax 4 4
Airway Obstruction 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Death 1 1
Cardiopulmonary Arrest 1 1
Hemothorax 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Ruptured Aneurysm 1 1
Thromboembolism 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medela AG Medical Technology II Apr-27-2021
2 Ohio Medical Corporation II Jan-11-2022
3 R A Medical Services II Sep-20-2023
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