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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tourniquet, pneumatic
Product CodeKCY
Regulation Number 878.5910
Device Class 1


Premarket Reviews
ManufacturerDecision
MCEWEN AND ASSOCIATES CONSULTING LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 145 145
2019 129 166
2020 119 144
2021 130 196
2022 90 132

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 209 209
Pressure Problem 94 94
Decrease in Pressure 92 263
Deflation Problem 49 49
Air Leak 35 35
Leak/Splash 32 32
Inflation Problem 31 31
Material Split, Cut or Torn 17 17
Delivered as Unsterile Product 12 12
Device Alarm System 11 11
Break 9 9
Material Puncture/Hole 9 9
Output Problem 9 9
Infusion or Flow Problem 9 9
Therapeutic or Diagnostic Output Failure 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Product Quality Problem 6 6
Device Emits Odor 6 6
Material Frayed 6 6
Patient Device Interaction Problem 6 6
Increase in Pressure 5 5
Self-Activation or Keying 5 5
Appropriate Term/Code Not Available 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Operates Differently Than Expected 4 4
Use of Device Problem 4 4
Calibration Problem 4 4
Material Integrity Problem 3 3
Battery Problem 3 3
Electromagnetic Interference 3 3
Unintended Deflation 3 3
Hole In Material 2 2
Fluid/Blood Leak 2 2
Difficult to Remove 2 2
Incorrect Measurement 2 2
No Apparent Adverse Event 2 2
No Pressure 2 2
Protective Measures Problem 2 2
Component Missing 2 2
Radiofrequency Interference (RFI) 2 2
Device Displays Incorrect Message 2 2
Patient-Device Incompatibility 1 1
Device Sensing Problem 1 1
Failure to Shut Off 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper Alarm 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Issue 1 1
Split 1 1
Defective Device 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Power Problem 1 1
Operating System Becomes Nonfunctional 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Insufficient Information 1 1
Torn Material 1 1
Noise, Audible 1 1
No Device Output 1 1
Overheating of Device 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Smoking 1 1
Problem with Sterilization 1 1
Stretched 1 1
Device Inoperable 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 0
Electrical /Electronic Property Problem 1 1
Low Audible Alarm 1 1
Thermal Decomposition of Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Degraded 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Key or Button Unresponsive/not Working 1 1
Sharp Edges 1 1
Device Fell 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 214 345
No Consequences Or Impact To Patient 191 246
No Known Impact Or Consequence To Patient 92 99
No Patient Involvement 79 102
Insufficient Information 21 46
Blood Loss 16 16
No Code Available 14 14
Skin Discoloration 5 5
Hematoma 4 4
Blister 4 4
Numbness 4 4
No Information 3 3
Bruise/Contusion 3 3
Burn(s) 2 2
Missing Value Reason 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Cyanosis 1 1
Ecchymosis 1 1
Tingling 1 1
Discharge 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Irritation 1 1
Laceration(s) 1 1
Pain 1 1
Loss of Range of Motion 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Delfi Medical Innovations, Inc. II May-06-2020
2 Stryker Instruments Div. of Stryker Corporation II Dec-02-2019
3 Stryker Sustainability Solutions II Feb-22-2022
4 Stryker Sustainability Solutions II Apr-27-2020
5 Zimmer Surgical Inc II Jan-28-2020
6 Zimmer Surgical Inc II Feb-14-2018
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