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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
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
A CUTE BABY, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANNABELLA LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
BABYATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CIMILRE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIXI RUIHONG ELECTRIC APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN RONGFENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVENFLO FEEDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXPLORAMED NC7, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU YONGYI INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HAENIM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA II MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMANI CO.
  SUBSTANTIALLY EQUIVALENT 3
LANSINOH LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD
  SUBSTANTIALLY EQUIVALENT 1
MAYBORN (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 1
MEDELA LLC
  SUBSTANTIALLY EQUIVALENT 3
MILKMATE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUIYOO BABY PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS CONSUMER LIFESTYLE - INNOVATION SITE EINDHOVEN
  SUBSTANTIALLY EQUIVALENT 2
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN TPH TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM CO.
  SUBSTANTIALLY EQUIVALENT 2
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 4
UZINMEDICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILLOW INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CAREBAO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 291 291
2019 168 168
2020 168 168
2021 119 119
2022 154 154
2023 182 182

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 297 297
Suction Problem 155 155
Patient Device Interaction Problem 144 144
Adverse Event Without Identified Device or Use Problem 67 67
Noise, Audible 54 54
Failure to Power Up 34 34
Insufficient Information 29 29
Fluid/Blood Leak 28 28
Break 27 27
Suction Failure 26 26
Inadequacy of Device Shape and/or Size 23 23
Power Problem 19 19
Device Operates Differently Than Expected 16 16
Smoking 16 16
Fitting Problem 13 13
Melted 13 13
Patient-Device Incompatibility 13 13
Unexpected Shutdown 13 13
Output Problem 12 12
Fire 10 10
Increase in Suction 10 10
Defective Device 9 9
Overheating of Device 9 9
Crack 9 9
Sparking 9 9
Pumping Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Gas/Air Leak 8 8
Obstruction of Flow 8 8
Defective Component 8 8
Product Quality Problem 7 7
Mechanical Problem 7 7
Charging Problem 7 7
Loss of Power 6 6
Improper or Incorrect Procedure or Method 5 5
Loose or Intermittent Connection 5 5
Battery Problem 5 5
Moisture or Humidity Problem 4 4
Device Emits Odor 4 4
Contamination 4 4
Premature Discharge of Battery 4 4
Device Displays Incorrect Message 4 4
Use of Device Problem 4 4
Vibration 3 3
Structural Problem 3 3
Energy Output Problem 3 3
Air Leak 3 3
Detachment of Device or Device Component 3 3
Connection Problem 2 2
Failure to Shut Off 2 2
Infusion or Flow Problem 2 2
Appropriate Term/Code Not Available 2 2
Pressure Problem 2 2
Intermittent Loss of Power 2 2
Key or Button Unresponsive/not Working 2 2
Backflow 2 2
Failure to Charge 2 2
Moisture Damage 2 2
Leak/Splash 2 2
Display or Visual Feedback Problem 2 2
Increased Pump Speed 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Microbial Contamination of Device 2 2
Component Missing 2 2
Fungus in Device Environment 1 1
Failure to Deliver 1 1
Device Inoperable 1 1
Failure to Align 1 1
Fumes or Vapors 1 1
Split 1 1
Pumping Stopped 1 1
Material Puncture/Hole 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Device Stops Intermittently 1 1
Electrical /Electronic Property Problem 1 1
Hole In Material 1 1
Image Display Error/Artifact 1 1
Kinked 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Unintended Collision 1 1
Misconnection 1 1
Circuit Failure 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Computer Software Problem 1 1
Loss of or Failure to Bond 1 1
Device Alarm System 1 1
Burst Container or Vessel 1 1
Disassembly 1 1
Disconnection 1 1
No Display/Image 1 1
Unintended Electrical Shock 1 1
Unclear Information 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 411 411
Inflammation 145 145
Breast Discomfort/Pain 143 143
No Known Impact Or Consequence To Patient 92 92
Pain 89 89
Bacterial Infection 41 41
Insufficient Information 31 31
No Clinical Signs, Symptoms or Conditions 27 27
No Information 27 27
No Code Available 27 27
Swelling 23 23
Fungal Infection 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Obstruction/Occlusion 12 12
Rash 12 12
No Consequences Or Impact To Patient 10 10
Fever 9 9
Erythema 7 7
Skin Infection 7 7
Superficial (First Degree) Burn 6 6
Skin Tears 6 6
Hemorrhage/Bleeding 6 6
Laceration(s) 5 5
Irritation 5 5
Bruise/Contusion 5 5
Injury 5 5
Burn, Thermal 5 5
Unspecified Reproductive System or Breast Problem 5 5
Unspecified Tissue Injury 4 4
Complaint, Ill-Defined 4 4
Reaction 4 4
Sepsis 4 4
Skin Irritation 4 4
Abscess 4 4
Itching Sensation 3 3
Occlusion 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Blister 3 3
Tissue Breakdown 2 2
Nipple Ulceration 2 2
Skin Inflammation 2 2
Fungus 2 2
Burn(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Tissue Damage 2 2
Nipple Sensation Changes 2 2
Chills 2 2
Perforation of Vessels 1 1
Burning Sensation 1 1
Depression 1 1
Urticaria 1 1
Discomfort 1 1
Tachycardia 1 1
Skin Discoloration 1 1
Increased Sensitivity 1 1
Calcium Deposits/Calcification 1 1
Eructate 1 1
Hepatitis 1 1
Electric Shock 1 1
Alteration In Body Temperature 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Kidney Infection 1 1
Patient Problem/Medical Problem 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1

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