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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
Regulation Description 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
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 50 50
2017 67 67
2018 44 44
2019 41 41
2020 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 68 68
Unraveled Material 44 44
Break 25 25
Difficult to Remove 16 16
Flaked 15 15
Material Fragmentation 13 13
Peeled/Delaminated 10 10
Material Frayed 9 9
Material Protrusion/Extrusion 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Material Deformation 6 6
Appropriate Term/Code Not Available 6 6
Stretched 5 5
Uncoiled 5 5
Contamination /Decontamination Problem 5 5
Fracture 4 4
Burst Container or Vessel 4 4
Insufficient Information 4 4
Material Split, Cut or Torn 4 4
Device Operates Differently Than Expected 4 4
Patient-Device Incompatibility 3 3
Material Twisted/Bent 3 3
Difficult to Advance 3 3
Device Contaminated During Manufacture or Shipping 3 3
Kinked 3 3
Wire 2 2
Guidewire 2 2
Detachment Of Device Component 2 2
Sticking 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Device 2 2
Detachment of Device or Device Component 2 2
Degraded 2 2
Inflation Problem 2 2
Material Puncture/Hole 2 2
Retraction Problem 1 1
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Split 1 1
Hole In Material 1 1
Crack 1 1
Tube 1 1
Bent 1 1
Human Factors Issue 1 1
Deformation Due to Compressive Stress 1 1
Problem with Sterilization 1 1
Noise, Audible 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Device Subassembly 1 1
Explosion 1 1
Unable to Obtain Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Dent in Material 1 1
Cuff 1 1
Connector 1 1
Leak/Splash 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 102 102
No Consequences Or Impact To Patient 49 49
No Code Available 35 35
Foreign Body In Patient 25 25
No Patient Involvement 21 21
Device Embedded In Tissue or Plaque 19 19
No Information 4 4
Blood Loss 3 3
Pain 3 3
Sepsis 3 3
Swelling 2 2
Skin Inflammation 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Death 2 2
Cardiac Perforation 2 2
Not Applicable 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Pneumonia 1 1
Anaphylactic Shock 1 1
Bacterial Infection 1 1
Occlusion 1 1
Perforation 1 1
Rash 1 1
Hypersensitivity/Allergic reaction 1 1
Cyst(s) 1 1
Dyspnea 1 1
Fatigue 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Thrombosis 1 1
Excessive Tear Production 1 1
Malaise 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
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