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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blood pressure cuff
Definition A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product CodeDXQ
Regulation Number 870.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDICARE COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN MARS MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HONSUN(NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LITTLE DOCTOR ELECTRONIC (NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI CAREMATE MEDICAL DEVICE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PLINMA TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU RENHUA INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI EXANOVO MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG LUDE TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 41 41
2020 5 5
2021 12 12
2022 3 3
2023 20 20
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 14 14
Adverse Event Without Identified Device or Use Problem 8 8
Unraveled Material 7 7
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4
Pressure Problem 4 4
Peeled/Delaminated 4 4
Break 3 3
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 2 2
Burst Container or Vessel 2 2
Material Fragmentation 2 2
Material Frayed 2 2
Material Puncture/Hole 2 2
Unable to Obtain Readings 2 2
Patient-Device Incompatibility 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Difficult to Advance 1 1
Gas/Air Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Remove 1 1
Delivered as Unsterile Product 1 1
Material Discolored 1 1
Material Twisted/Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Low Readings 1 1
Dent in Material 1 1
Defective Device 1 1
Air/Gas in Device 1 1
Problem with Sterilization 1 1
Stretched 1 1
Insufficient Information 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Known Impact Or Consequence To Patient 12 12
Insufficient Information 10 10
No Consequences Or Impact To Patient 9 9
No Code Available 7 7
No Patient Involvement 6 6
Foreign Body In Patient 5 5
No Information 3 3
Death 2 2
Sepsis 2 2
Rash 2 2
Pain 2 2
Contact Dermatitis 2 2
Caustic/Chemical Burns 2 2
Superficial (First Degree) Burn 1 1
Skin Infection 1 1
Not Applicable 1 1
Skin Inflammation/ Irritation 1 1
Myalgia 1 1
Skin Discoloration 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Loss of Range of Motion 1 1
Viral Infection 1 1
Skin Inflammation 1 1
Eye Injury 1 1
Muscle/Tendon Damage 1 1
Anaphylactic Shock 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Cerebrospinal Fluid Leakage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Information Technologies Inc II Jun-06-2024
2 ICU Medical, Inc. II May-01-2020
3 Suntech Medical, Inc. II Aug-14-2019
4 Volcano Corp II Jun-16-2022
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