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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
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 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 BOKANG INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
  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 2 2

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
Flaked 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Peeled/Delaminated 7 7
Difficult to Remove 7 7
Material Frayed 6 6
Material Deformation 6 6
Uncoiled 5 5
Burst Container or Vessel 4 4
Device Operates Differently Than Expected 4 4
Material Split, Cut or Torn 4 4
Difficult to Advance 3 3
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 3 3
Insufficient Information 3 3
Kinked 3 3
Stretched 3 3
Unable to Obtain Readings 3 3
Sticking 2 2
Material Puncture/Hole 2 2
Inflation Problem 2 2
Detachment Of Device Component 2 2
Fracture 2 2
Degraded 2 2
Material Protrusion/Extrusion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Human Factors Issue 1 1
Material Twisted/Bent 1 1
Material Integrity Problem 1 1
Noise, Audible 1 1
Explosion 1 1
Air/Gas in Device 1 1
Material Discolored 1 1
Crack 1 1
Bent 1 1
Hole In Material 1 1
Leak/Splash 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Dent in Material 1 1
Split 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 80 80
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
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 4 4
No Information 3 3
Pain 3 3
Death 2 2
Rash 2 2
Sepsis 2 2
Swelling 2 2
Skin Inflammation 2 2
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1
Thrombosis 1 1
Skin Discoloration 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
Not Applicable 1 1
Superficial (First Degree) Burn 1 1
Myalgia 1 1
Malaise 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ICU Medical, Inc. II May-01-2020
2 ICU Medical, Inc. II May-09-2018
3 Suntech Medical, Inc. II Aug-14-2019
4 Volcano Corp II Jun-16-2022
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