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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 8 8

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
Pressure Problem 4 4
Material Deformation 4 4
Peeled/Delaminated 4 4
Break 3 3
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Burst Container or Vessel 2 2
Patient-Device Incompatibility 2 2
Material Puncture/Hole 2 2
Contamination /Decontamination Problem 2 2
Material Frayed 2 2
Biocompatibility 2 2
Unable to Obtain Readings 2 2
Material Fragmentation 2 2
Material Protrusion/Extrusion 2 2
Air/Gas in Device 1 1
Dent in Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Advance 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Information 1 1
Stretched 1 1
Detachment of Device or Device Component 1 1
Defective Device 1 1
Delivered as Unsterile Product 1 1
Explosion 1 1
Gas/Air Leak 1 1
Material Twisted/Bent 1 1
Problem with Sterilization 1 1
Difficult to Remove 1 1
Low Readings 1 1
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
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
Caustic/Chemical Burns 2 2
Death 2 2
Pain 2 2
Rash 2 2
Sepsis 2 2
Skin Discoloration 1 1
Loss of Range of Motion 1 1
Eye Injury 1 1
Anaphylactic Shock 1 1
Cerebrospinal Fluid Leakage 1 1
Superficial (First Degree) Burn 1 1
Myalgia 1 1
Skin Inflammation 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Not Applicable 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 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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