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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, breast, powered
Regulation Description Powered breast pump.
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
A CUTE BABY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIMILRE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
EXPLORAMED NC7, INC
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU JINXINBAO ELECTRONIC CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIMERICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA
  SUBSTANTIALLY EQUIVALENT 4
MEDELA HOLDING AG
  SUBSTANTIALLY EQUIVALENT 5
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM CO.
  SUBSTANTIALLY EQUIVALENT 2
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 4
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 152
Suction Problem 66
Smoking 33
Device Operates Differently Than Expected 23
Decrease in Suction 19
Adverse Event Without Identified Device or Use Problem 18
Insufficient Information 14
Sparking 12
Inappropriate Shock 8
Break 4
Housing 3
Fire 3
Noise, Audible 3
Increase in Suction 2
Appropriate Term/Code Not Available 2
Protective Measures Problem 2
Inadequacy of Device Shape and/or Size 2
Power Problem 2
Melted 2
Wire 2
Use of Device Problem 2
Unintended Electrical Shock 1
Transformer 1
Complete Blockage 1
Device Handling Problem 1
Pump 1
Component Misassembled 1
Crack 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Overheating of Device 1
Sharp Edges 1
Charred 1
Device Inoperable 1
Failure to Shut Off 1
Failure to Charge 1
Obstruction of Flow 1
Patient-Device Incompatibility 1
Detachment of Device or device Component 1
Total Device Problems 391

Recalls
Manufacturer Recall Class Date Posted
1 AMEDA, INC. III Feb-15-2018

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