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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
NINGBO ALBERT NOVOSINO CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI CAREMATE MEDICAL DEVICE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HULU DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MEDKE 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 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU BOKANG INSTRUMENTS CO., LTD
  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
2017 67 67
2018 44 44
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 37 37
Break 20 20
Unraveled Material 17 17
Material Fragmentation 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Flaked 8 8
Material Deformation 7 7
Difficult to Remove 7 7
Peeled/Delaminated 7 7
Material Frayed 6 6
Uncoiled 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Burst Container or Vessel 4 4
Material Split, Cut or Torn 4 4
Pressure Problem 4 4
Device Operates Differently Than Expected 4 4
Kinked 3 3
Patient-Device Incompatibility 3 3
Difficult to Advance 3 3
Insufficient Information 3 3
Material Integrity Problem 3 3
Unable to Obtain Readings 3 3
Stretched 3 3
Detachment of Device or Device Component 3 3
Material Puncture/Hole 2 2
Detachment Of Device Component 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Degraded 2 2
Fracture 2 2
Material Protrusion/Extrusion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Inflation Problem 2 2
Sticking 2 2
Hole In Material 1 1
Improper or Incorrect Procedure or Method 1 1
Explosion 1 1
Device Contamination with Chemical or Other Material 1 1
Device Sensing Problem 1 1
Low Readings 1 1
Noise, Audible 1 1
Retraction Problem 1 1
Delivered as Unsterile Product 1 1
Bent 1 1
Out-Of-Box Failure 1 1
Problem with Sterilization 1 1
Material Twisted/Bent 1 1
Gas/Air Leak 1 1
Dent in Material 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 80 80
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 16 16
No Patient Involvement 15 15
No Code Available 14 14
Foreign Body In Patient 13 13
Device Embedded In Tissue or Plaque 11 11
Insufficient Information 10 10
No Information 3 3
Pain 3 3
Death 2 2
Rash 2 2
Sepsis 2 2
Swelling 2 2
Contact Dermatitis 2 2
Skin Inflammation 2 2
Caustic/Chemical Burns 2 2
Blood Loss 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Not Applicable 1 1
Superficial (First Degree) Burn 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Muscle/Tendon Damage 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Tachycardia 1 1
Thrombosis 1 1
Skin Discoloration 1 1
Myalgia 1 1
Viral Infection 1 1
Malaise 1 1
Eye Injury 1 1
Fatigue 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Perforation 1 1
Loss of Range of Motion 1 1
Anaphylactic Shock 1 1
Bacterial Infection 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 ICU Medical, Inc. II May-09-2018
4 Suntech Medical, Inc. II Aug-14-2019
5 Volcano Corp II Jun-16-2022
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